BR112013007457A8 - Formulações farmacêuticas contendo rifaximina, processos para a sua obtenção e método de tratar doença intestinal - Google Patents

Formulações farmacêuticas contendo rifaximina, processos para a sua obtenção e método de tratar doença intestinal

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Publication number
BR112013007457A8
BR112013007457A8 BR112013007457A BR112013007457A BR112013007457A8 BR 112013007457 A8 BR112013007457 A8 BR 112013007457A8 BR 112013007457 A BR112013007457 A BR 112013007457A BR 112013007457 A BR112013007457 A BR 112013007457A BR 112013007457 A8 BR112013007457 A8 BR 112013007457A8
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BR
Brazil
Prior art keywords
obtaining
processes
treatment
pharmaceutical formulations
formulations containing
Prior art date
Application number
BR112013007457A
Other languages
English (en)
Other versions
BR112013007457A2 (pt
Inventor
Claudio Viscomi Giuseppe
Maffei Paola
Grimaldi Maria
Bottoni Giuseppe
Original Assignee
Alfa Wassermann Spa
Alfasigma Spa
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=43737853&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112013007457(A8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alfa Wassermann Spa, Alfasigma Spa filed Critical Alfa Wassermann Spa
Publication of BR112013007457A2 publication Critical patent/BR112013007457A2/pt
Publication of BR112013007457A8 publication Critical patent/BR112013007457A8/pt

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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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/4353—Heterocyclic 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
    • A61K31/437—Heterocyclic 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
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K9/14—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
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • 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
    • 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
    • A61P1/04—Drugs 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
    • 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
    • A61P1/12—Antidiarrhoeals
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Medicinal Preparation (AREA)

Abstract

FORMULAÇÕES FARMACÊUTICAS CONTENDO RIFAXIMINA, PROCESSOS PARA A SUA OBTENÇÃO E MÉTODO DE TRATAR DOENÇA INTESTINAL. A presente invenção refere-se aos comprimidos gastrorresistentes contendo rifaximina, obtidos por meio de microgranulos gastrorresistentes, caracterizados pelo fato de que eles inibem a liberação da rifaximina em valores de pH entre 1,5 4,0, e eles permitem a sua liberação em valores de pH entre 5,0 e 7.5, os processos para a sua obtenção e o seu uso no tratamento e na prevenção de doenças que se derivam direta ou indiretamente de doenças inflamatórias do intestino.
BR112013007457A 2010-09-22 2011-09-21 Formulações farmacêuticas contendo rifaximina, processos para a sua obtenção e método de tratar doença intestinal BR112013007457A8 (pt)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
ITBO20100567 2010-09-22
ITBO20100638 2010-10-22
ITBO2011A000012A IT1403847B1 (it) 2010-09-22 2011-01-19 Composizioni farmaceutiche comprendenti rifaximina e loro uso.
PCT/IB2011/054133 WO2012038898A1 (en) 2010-09-22 2011-09-21 Pharmaceutical formulations containing rifaximin, processes for their obtainment and method of treating intestinal disease

Publications (2)

Publication Number Publication Date
BR112013007457A2 BR112013007457A2 (pt) 2016-07-12
BR112013007457A8 true BR112013007457A8 (pt) 2017-12-26

Family

ID=43737853

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013007457A BR112013007457A8 (pt) 2010-09-22 2011-09-21 Formulações farmacêuticas contendo rifaximina, processos para a sua obtenção e método de tratar doença intestinal

Country Status (31)

Country Link
US (4) US20120245192A1 (pt)
EP (1) EP2618819B1 (pt)
JP (1) JP5918242B2 (pt)
KR (2) KR20180001586A (pt)
CN (1) CN103118666A (pt)
AU (1) AU2011306444B2 (pt)
BR (1) BR112013007457A8 (pt)
CA (1) CA2809509C (pt)
CL (1) CL2013000677A1 (pt)
CO (1) CO6680695A2 (pt)
CY (1) CY1119746T1 (pt)
DK (1) DK2618819T3 (pt)
EA (1) EA027588B1 (pt)
ES (1) ES2649063T3 (pt)
HR (1) HRP20171734T1 (pt)
HU (1) HUE034620T2 (pt)
IL (1) IL271927A (pt)
IT (1) IT1403847B1 (pt)
LT (1) LT2618819T (pt)
ME (1) ME03044B (pt)
MX (1) MX349719B (pt)
NO (1) NO2618819T3 (pt)
PL (1) PL2618819T3 (pt)
PT (1) PT2618819T (pt)
RS (1) RS56708B1 (pt)
SG (2) SG10201507869UA (pt)
SI (1) SI2618819T1 (pt)
TN (1) TN2013000073A1 (pt)
UA (1) UA110212C2 (pt)
WO (1) WO2012038898A1 (pt)
ZA (1) ZA201301391B (pt)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1698630E (pt) 2005-03-03 2014-09-15 Alfa Wassermann Spa Novas formas polimorfas de rifaximina, processos para a sua produção e a sua utilização nas preparações medicinais
ITBO20050123A1 (it) 2005-03-07 2005-06-06 Alfa Wassermann Spa Formulazioni farmaceutiche gastroresistenti contenenti rifaximina
ITMI20061692A1 (it) 2006-09-05 2008-03-06 Alfa Wassermann Spa Uso di polioli per ottenere forme polimorfe stabili di rifaximina
IT1398550B1 (it) 2010-03-05 2013-03-01 Alfa Wassermann Spa Formulazioni comprendenti rifaximina utili per ottenere un effetto prolungato nel tempo
ITBO20110461A1 (it) 2011-07-29 2013-01-30 Alfa Wassermann Spa Composizioni farmaceutiche comprendenti rifaximina, processi per la loro preparazione e loro uso nel trattamento di infezioni vaginali.
US9849090B2 (en) 2012-12-12 2017-12-26 Sun Pharmaceutical Industries Limited Pharmaceutical compositions of rifaximin
PL2983647T3 (pl) * 2013-04-12 2021-01-25 Alfasigma S.P.A. Podawanie nlpz oraz związane z tym składniki, sposoby i układy
CN103340856A (zh) * 2013-07-09 2013-10-09 荣港生技医药科技（北京）有限公司 一种利福昔明药物组合物及其制备方法
US20160206564A1 (en) * 2013-09-27 2016-07-21 Ira Milton Trachtman Compositions and methods for treatment and prophylaxis of gastrointestinal diseases
NZ723571A (en) 2014-05-12 2020-02-28 Alfasigma Spa New solvated crystal form of rifaximin, production, compositions and uses thereof
JP6608193B2 (ja) * 2014-06-27 2019-11-20 花王株式会社 固形状組成物
WO2016063289A2 (en) * 2014-10-22 2016-04-28 Strides Arcolab Limited Pharmaceutical tablet compositions comprising rifaximin
EP3518924B1 (en) 2016-09-30 2022-08-10 Salix Pharmaceuticals, Inc. Solid dispersion forms of rifaximin
WO2018197538A1 (en) * 2017-04-26 2018-11-01 Sandoz Ag Oral dosage form comprising rifaximin in form beta
EP3846784A1 (en) 2018-09-06 2021-07-14 Fachhochschule Nordwestschweiz Controlled drug release formulation
JP2022548788A (ja) * 2019-09-24 2022-11-21 バウシュ ヘルス アイルランド リミテッド リファキシミン液体製剤

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20032144A1 (it) 2003-11-07 2005-05-08 Alfa Wassermann Spa Forme polimorfe di rifaximina, processi per ottenerle e
US7902206B2 (en) 2003-11-07 2011-03-08 Alfa Wassermann, S.P.A. Polymorphic forms α, β and γ of rifaximin
US20080262024A1 (en) 2003-11-07 2008-10-23 Giuseppe Claudio Viscomi Rifaximin compositions and method of use
US7906542B2 (en) * 2004-11-04 2011-03-15 Alfa Wassermann, S.P.A. Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin
PT1698630E (pt) 2005-03-03 2014-09-15 Alfa Wassermann Spa Novas formas polimorfas de rifaximina, processos para a sua produção e a sua utilização nas preparações medicinais
ITBO20050123A1 (it) * 2005-03-07 2005-06-06 Alfa Wassermann Spa Formulazioni farmaceutiche gastroresistenti contenenti rifaximina
ITMI20061692A1 (it) 2006-09-05 2008-03-06 Alfa Wassermann Spa Uso di polioli per ottenere forme polimorfe stabili di rifaximina
WO2008035108A1 (en) 2006-09-21 2008-03-27 Ray Mason Engine assemblies
ITMI20071241A1 (it) 2007-06-20 2008-12-21 Solmag S P A Processo per la preparazione di rifaximina amorfa e rifaximina amorfa cosi' ottenuta
WO2009008005A1 (en) * 2007-07-06 2009-01-15 Lupin Limited Pharmaceutical compositions of rifaximin
US7709634B2 (en) 2007-09-20 2010-05-04 Apotex Pharmachem Inc. Amorphous form of rifaximin and processes for its preparation
CA2716830C (en) 2008-02-25 2019-01-08 Salix Pharmaceuticals, Ltd. Forms of rifaximin and uses thereof

Also Published As

Publication number Publication date
IL271927A (en) 2020-02-27
KR102049253B1 (ko) 2019-11-28
SG188271A1 (en) 2013-04-30
SG10201507869UA (en) 2015-10-29
US20120245192A1 (en) 2012-09-27
CY1119746T1 (el) 2018-06-27
AU2011306444A1 (en) 2013-03-21
NO2618819T3 (pt) 2018-03-31
BR112013007457A2 (pt) 2016-07-12
TN2013000073A1 (en) 2014-06-25
US20150080421A1 (en) 2015-03-19
ME03044B (me) 2018-10-20
ZA201301391B (en) 2014-04-30
EA027588B1 (ru) 2017-08-31
UA110212C2 (uk) 2015-12-10
RS56708B1 (sr) 2018-03-30
PT2618819T (pt) 2017-12-11
WO2012038898A1 (en) 2012-03-29
MX2013003243A (es) 2013-05-22
CA2809509C (en) 2016-04-26
CO6680695A2 (es) 2013-05-31
JP2013537900A (ja) 2013-10-07
EA201390310A1 (ru) 2013-11-29
AU2011306444B2 (en) 2015-04-23
EP2618819A1 (en) 2013-07-31
JP5918242B2 (ja) 2016-05-18
ITBO20110012A1 (it) 2012-03-23
US20210244714A1 (en) 2021-08-12
CA2809509A1 (en) 2012-03-29
CN103118666A (zh) 2013-05-22
PL2618819T3 (pl) 2018-01-31
HRP20171734T1 (hr) 2018-01-26
LT2618819T (lt) 2018-02-26
IT1403847B1 (it) 2013-11-08
EP2618819B1 (en) 2017-11-01
US20170071916A1 (en) 2017-03-16
DK2618819T3 (en) 2017-12-11
SI2618819T1 (en) 2018-01-31
KR20180001586A (ko) 2018-01-04
HUE034620T2 (en) 2018-02-28
MX349719B (es) 2017-08-09
CL2013000677A1 (es) 2013-07-19
KR20130106400A (ko) 2013-09-27
ES2649063T3 (es) 2018-01-09

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