CN102655752A - 包含整合酶抑制剂的固体药物组合物 - Google Patents

包含整合酶抑制剂的固体药物组合物 Download PDF

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Publication number
CN102655752A
CN102655752A CN2010800593740A CN201080059374A CN102655752A CN 102655752 A CN102655752 A CN 102655752A CN 2010800593740 A CN2010800593740 A CN 2010800593740A CN 201080059374 A CN201080059374 A CN 201080059374A CN 102655752 A CN102655752 A CN 102655752A
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CN
China
Prior art keywords
amount
compressed tablet
raltegravir
superdisintegrant
iii
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN2010800593740A
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English (en)
Chinese (zh)
Inventor
M.马霍尔
李峰
马德成
S.索特希维拉
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck Sharp and Dohme LLC
Original Assignee
Merck Sharp and Dohme LLC
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43922462&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN102655752(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Merck Sharp and Dohme LLC filed Critical Merck Sharp and Dohme LLC
Priority to CN201610500807.0A priority Critical patent/CN106074411A/zh
Publication of CN102655752A publication Critical patent/CN102655752A/zh
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/4245—Oxadiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • AIDS & HIV (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN2010800593740A 2009-10-26 2010-10-21 包含整合酶抑制剂的固体药物组合物 Pending CN102655752A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201610500807.0A CN106074411A (zh) 2009-10-26 2010-10-21 包含整合酶抑制剂的固体药物组合物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25486909P 2009-10-26 2009-10-26
US61/254869 2009-10-26
PCT/US2010/053507 WO2011053504A1 (en) 2009-10-26 2010-10-21 Solid pharmaceutical compositions containing an integrase inhibitor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201610500807.0A Division CN106074411A (zh) 2009-10-26 2010-10-21 包含整合酶抑制剂的固体药物组合物

Publications (1)

Publication Number Publication Date
CN102655752A true CN102655752A (zh) 2012-09-05

Family

ID=43922462

Family Applications (2)

Application Number Title Priority Date Filing Date
CN2010800593740A Pending CN102655752A (zh) 2009-10-26 2010-10-21 包含整合酶抑制剂的固体药物组合物
CN201610500807.0A Pending CN106074411A (zh) 2009-10-26 2010-10-21 包含整合酶抑制剂的固体药物组合物

Family Applications After (1)

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CN201610500807.0A Pending CN106074411A (zh) 2009-10-26 2010-10-21 包含整合酶抑制剂的固体药物组合物

Country Status (26)

Country Link
US (2) US9649311B2 (enExample)
EP (2) EP3970702A1 (enExample)
JP (2) JP6122639B2 (enExample)
KR (1) KR101835893B1 (enExample)
CN (2) CN102655752A (enExample)
AU (1) AU2010313571B2 (enExample)
BR (1) BR112012009857A8 (enExample)
CA (1) CA2777937C (enExample)
CO (1) CO6531485A2 (enExample)
CY (1) CY1124914T1 (enExample)
DK (1) DK2493312T3 (enExample)
ES (1) ES2898348T3 (enExample)
HR (1) HRP20211826T1 (enExample)
HU (1) HUE057248T2 (enExample)
IL (1) IL219369A (enExample)
IN (1) IN2012DN03377A (enExample)
LT (1) LT2493312T (enExample)
MX (1) MX345227B (enExample)
MY (1) MY162494A (enExample)
PL (1) PL2493312T3 (enExample)
PT (1) PT2493312T (enExample)
RS (1) RS62600B1 (enExample)
RU (1) RU2602865C2 (enExample)
SI (1) SI2493312T1 (enExample)
WO (1) WO2011053504A1 (enExample)
ZA (1) ZA201203012B (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105237526A (zh) * 2014-06-20 2016-01-13 朱靖华 一种抗艾滋病毒药物及其制备方法
US10004721B2 (en) 2012-10-23 2018-06-26 Cipla Limited Pharmaceutical antiretroviral composition

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3970702A1 (en) 2009-10-26 2022-03-23 Merck Sharp & Dohme Corp. Solid pharmaceutical compositions containing an integrase inhibitor
CA2833006A1 (en) * 2011-04-22 2012-10-26 Merck Sharp & Dohme Corp. Taste-masked formulations of raltegravir
US20150166520A1 (en) * 2012-07-20 2015-06-18 Merck Sharp & Dohme Corp. Amido-substituted pyrimidinone derivatives useful for the treatment of hiv infection
WO2014064711A2 (en) * 2012-10-22 2014-05-01 Hetero Research Foundation Methods of administering raltegravir and raltegravir compositions
WO2015006177A1 (en) * 2013-07-11 2015-01-15 Merck Sharp & Dohme Corp. Formulations for cathepsin k inhibitors with vitamin d
JP7023054B2 (ja) * 2017-04-05 2022-02-21 東和薬品株式会社 レベチラセタム含有医薬組成物及びその製造方法
KR102497051B1 (ko) * 2018-01-19 2023-02-09 길리애드 사이언시즈, 인코포레이티드 빅테그라비르의 대사물
WO2019236395A1 (en) * 2018-06-06 2019-12-12 Merck Sharp & Dohme Corp. Formulations of raltegravir
RU2688235C1 (ru) * 2018-06-19 2019-05-21 Федеральное государственное бюджетное образовательное учреждение высшего образования "Пермский государственный национальный исследовательский университет" Фармацевтическая противодиабетическая композиция на основе замещенного тиофенкарбоксилата и способ её получения
PE20211489A1 (es) 2018-08-31 2021-08-11 Opko Ireland Global Holdings Ltd Formas de dosificacion pediatricas de vitamina d, metodos de elaboracion y uso

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CN101068550A (zh) * 2004-12-03 2007-11-07 默克公司 含有释放速度控制组分的羧酰胺人类免疫缺陷整合酶抑制剂药物制剂
WO2008043167A1 (en) * 2006-10-12 2008-04-17 Pharmascience Inc. Pharmaceutical compositions comprising intra- and extra- granular fractions
US20080118559A1 (en) * 2004-12-03 2008-05-22 Cruanes Maria T Pharmaceutical Composition Containing an Anti-Nucleating Agent
WO2009002823A2 (en) * 2007-06-22 2008-12-31 Bristol-Myers Squibb Company Tableted compositions containing atazanavir

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GB9922963D0 (en) 1999-09-28 1999-12-01 Pfizer Ltd Polymorphic salt
FR2795962B1 (fr) * 1999-07-08 2003-05-09 Prographarm Laboratoires Procede de fabrication de granules enrobes a gout masque et liberation immediate du principe actif
AU777824B2 (en) 1999-11-24 2004-11-04 Merck Sharp & Dohme Corp. Gamma-hydroxy-2-(fluoroalkylaminocarbonyl)-1- piperazinepentanamides as HIV protease inhibitors
WO2002030931A2 (en) 2000-10-12 2002-04-18 Merck & Co., Inc. Aza- and polyaza-naphthalenyl carboxamides useful as hiv integrase inhibitors
DK1441734T3 (da) 2001-10-26 2007-06-11 Angeletti P Ist Richerche Bio Dihydroxypyrimidin-carboxamid-inhibitorer a HIV-integrase
CA2463976C (en) 2001-10-26 2007-02-13 Benedetta Crescenzi N-substituted hydroxypyrimidinone carboxamide inhibitors of hiv integrase
WO2003086319A2 (en) 2002-04-10 2003-10-23 Merck & Co., Inc. Pharmaceutical compositions containing an hiv integrase inhibitor and a nonionic surfactant
KR20050087865A (ko) 2002-12-27 2005-08-31 이스티투토 디 리세르쉐 디 비올로지아 몰레콜라레 피. 안젤레티에스.피.에이. ＨＩＶ 인테그라제 억제제로서 유용한테트라하이드로-4Ｈ-피리도[1,2-ａ]피리미딘 및 관련화합물
ATE500819T1 (de) 2003-12-31 2011-03-15 Bend Res Inc Stabilisierte pharmazeutische feste zusammensetzungen von arzneimitteln mit geringer löslichkeit, poloxameren und stabilisierenden polymeren
US7829720B2 (en) 2004-05-04 2010-11-09 Bristol-Myers Squibb Company Process for preparing atazanavir bisulfate and novel forms
KR20070085702A (ko) 2004-12-03 2007-08-27 머크 앤드 캄파니 인코포레이티드 Ｕｇｔ1ａ1에 의해 대사된 약물의 약력학을 개선시키기위한 아타자나비르의 용도
UA87884C2 (uk) * 2004-12-03 2009-08-25 Мерк Энд Ко., Инк. Безводна кристалічна калієва сіль інгібітора віл-інтегрази
WO2007087188A2 (en) 2006-01-20 2007-08-02 Merck & Co., Inc. Taste-masked tablets and granules
US7687509B2 (en) * 2007-07-09 2010-03-30 Concert Pharmaceuticals Inc. Pyrimidinecarboxamide derivatives
US8372431B2 (en) 2007-10-26 2013-02-12 Bial-Portela & C.A., S.A. Pharmaceutical composition comprising licarbazepine acetate
EP3970702A1 (en) 2009-10-26 2022-03-23 Merck Sharp & Dohme Corp. Solid pharmaceutical compositions containing an integrase inhibitor

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101068550A (zh) * 2004-12-03 2007-11-07 默克公司 含有释放速度控制组分的羧酰胺人类免疫缺陷整合酶抑制剂药物制剂
US20080118559A1 (en) * 2004-12-03 2008-05-22 Cruanes Maria T Pharmaceutical Composition Containing an Anti-Nucleating Agent
WO2008043167A1 (en) * 2006-10-12 2008-04-17 Pharmascience Inc. Pharmaceutical compositions comprising intra- and extra- granular fractions
WO2009002823A2 (en) * 2007-06-22 2008-12-31 Bristol-Myers Squibb Company Tableted compositions containing atazanavir

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10004721B2 (en) 2012-10-23 2018-06-26 Cipla Limited Pharmaceutical antiretroviral composition
US10420727B2 (en) 2012-10-23 2019-09-24 Cipla Limited Pharmaceutical antiretroviral composition
CN105237526A (zh) * 2014-06-20 2016-01-13 朱靖华 一种抗艾滋病毒药物及其制备方法
CN105237526B (zh) * 2014-06-20 2018-01-23 朱靖华 一种抗艾滋病毒药物及其制备方法

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US9649311B2 (en) 2017-05-16
CA2777937C (en) 2017-08-29
PT2493312T (pt) 2021-11-25
JP6122639B2 (ja) 2017-04-26
US20170231993A1 (en) 2017-08-17
US20120213851A1 (en) 2012-08-23
PL2493312T3 (pl) 2022-01-03
HUE057248T2 (hu) 2022-04-28
US10772888B2 (en) 2020-09-15
RU2012121857A (ru) 2013-12-10
BR112012009857A8 (pt) 2023-04-11
IL219369A0 (en) 2012-06-28
EP3970702A1 (en) 2022-03-23
JP2013508395A (ja) 2013-03-07
SI2493312T1 (sl) 2021-12-31
IN2012DN03377A (enExample) 2015-10-23
KR101835893B1 (ko) 2018-04-19
AU2010313571B2 (en) 2014-07-31
AU2010313571A1 (en) 2012-06-07
HRP20211826T1 (hr) 2022-03-04
MX345227B (es) 2017-01-20
CA2777937A1 (en) 2011-05-05
LT2493312T (lt) 2022-01-10
MX2012004903A (es) 2012-06-14
RS62600B1 (sr) 2021-12-31
ES2898348T3 (es) 2022-03-07
BR112012009857A2 (pt) 2015-09-29
CN106074411A (zh) 2016-11-09
EP2493312B1 (en) 2021-10-20
ZA201203012B (en) 2012-12-27
CY1124914T1 (el) 2023-01-05
KR20120102063A (ko) 2012-09-17
MY162494A (en) 2017-06-15
WO2011053504A1 (en) 2011-05-05
EP2493312A1 (en) 2012-09-05
JP2016034962A (ja) 2016-03-17
RU2602865C2 (ru) 2016-11-20
DK2493312T3 (da) 2021-12-13
CO6531485A2 (es) 2012-09-28
EP2493312A4 (en) 2013-07-10
IL219369A (en) 2017-06-29

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