MX2016008591A - Composicion combinada de bromuro de glicopirronio y formoterol en solucion estable presurizada para aerosol. - Google Patents

Composicion combinada de bromuro de glicopirronio y formoterol en solucion estable presurizada para aerosol.

Info

Publication number
MX2016008591A
MX2016008591A MX2016008591A MX2016008591A MX2016008591A MX 2016008591 A MX2016008591 A MX 2016008591A MX 2016008591 A MX2016008591 A MX 2016008591A MX 2016008591 A MX2016008591 A MX 2016008591A MX 2016008591 A MX2016008591 A MX 2016008591A
Authority
MX
Mexico
Prior art keywords
solution composition
glycopyrronium bromide
aerosol solution
hydroxy
active ingredient
Prior art date
Application number
MX2016008591A
Other languages
English (en)
Other versions
MX368834B (es
Inventor
Bonelli Sauro
Copelli Diego
Dagli Alberi Massimiliano
Usberti Francesca
Zambelli Enrico
Original Assignee
Chiesi Farm 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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49886776&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2016008591(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chiesi Farm Spa filed Critical Chiesi Farm Spa
Publication of MX2016008591A publication Critical patent/MX2016008591A/es
Publication of MX368834B publication Critical patent/MX368834B/es

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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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/573—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 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/124—Aerosols; Foams characterised by the propellant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/007—Mechanical counters
    • A61M15/0071—Mechanical counters having a display or indicator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0086—Inhalation chambers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
    • B65D83/44—Valves specially adapted therefor; Regulating devices
    • B65D83/52—Valves specially adapted therefor; Regulating devices for metering
    • B65D83/54—Metering valves ; Metering valve assemblies
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/14—Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
    • B65D83/75—Aerosol containers not provided for in groups B65D83/16 - B65D83/74
    • B65D83/752—Aerosol containers not provided for in groups B65D83/16 - B65D83/74 characterised by the use of specific products or propellants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M2039/226—Spindles or actuating means

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Dispersion Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pain & Pain Management (AREA)
  • Mechanical Engineering (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Cosmetics (AREA)
  • Steroid Compounds (AREA)

Abstract

La invención se refiere a una composición en solución para aerosol para utilizarse con un inhalador presurizado de dosis medida, que comprende bromuro de glicopirronio y formoterol, o una sal del mismo, opcionalmente en combinación con uno o más ingredientes activos adicionales, estabilizado con una cantidad seleccionada de un ácido mineral y donde la cantidad del producto de degradación N- (3-bromo) - [2-hidroxi -5- [1-hidroxi-2- [1- (4-metoxifenil)propan-2-ilamino] etil] fenil]formamida es menor que el límite de cuantificación, cuando se almacena en condiciones de envejecimiento acelerado a 25°C y 60% de humedad relativa (RH) durante por lo menos 6 meses en un envase de aerosol provisto de una válvula dosificadora que tiene por lo menos una junta de caucho butílico. Los uno o más ingredientes activos opcionales pueden ser corticosteroides para inhalación que se pueden seleccionar entre: dipropionato de beclometasona, budesonida o su 22R-epímero, ciclesonida, flunisolida, propionato de fluticasona, furoato de fluticasona, furoato de mometasona, etc.
MX2016008591A 2013-12-30 2014-12-23 Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosol. MX368834B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13199783 2013-12-30
PCT/EP2014/079258 WO2015101575A1 (en) 2013-12-30 2014-12-23 Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination

Publications (2)

Publication Number Publication Date
MX2016008591A true MX2016008591A (es) 2016-09-26
MX368834B MX368834B (es) 2019-10-18

Family

ID=49886776

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016008591A MX368834B (es) 2013-12-30 2014-12-23 Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosol.

Country Status (36)

Country Link
US (3) US20150182459A1 (es)
EP (1) EP3096737B1 (es)
JP (2) JP6534397B2 (es)
KR (1) KR101865131B1 (es)
CN (2) CN113143894A (es)
AR (1) AR098983A1 (es)
AU (1) AU2014375300B2 (es)
BR (1) BR112016014586A2 (es)
CA (1) CA2935302C (es)
CL (1) CL2016001652A1 (es)
CY (1) CY1120205T1 (es)
DK (1) DK3096737T3 (es)
EA (1) EA033228B1 (es)
ES (1) ES2666905T4 (es)
GE (1) GEP20186870B (es)
HR (1) HRP20180944T1 (es)
HU (1) HUE039359T2 (es)
IL (1) IL246502B (es)
LT (1) LT3096737T (es)
MA (1) MA39154A1 (es)
ME (1) ME03076B (es)
MX (1) MX368834B (es)
MY (1) MY176191A (es)
NO (1) NO3096737T3 (es)
PE (1) PE20161132A1 (es)
PH (1) PH12016501269B1 (es)
PL (1) PL3096737T3 (es)
PT (1) PT3096737T (es)
RS (1) RS57269B1 (es)
SA (1) SA516371428B1 (es)
SG (1) SG11201605309UA (es)
SI (1) SI3096737T1 (es)
TN (1) TN2016000262A1 (es)
TR (1) TR201809356T4 (es)
UA (1) UA117846C2 (es)
WO (1) WO2015101575A1 (es)

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WO2011076842A2 (en) 2009-12-23 2011-06-30 Chiesi Farmaceutici S.P.A. Aerosol formulation for copd
SG11201605311UA (en) * 2013-12-30 2016-07-28 Chiesi Farma Spa Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination
ME03076B (me) * 2013-12-30 2019-01-20 Chiesi Farm Spa Stabilna pod priтiskom kompozicija aerosolnog rastvora glikopironijum bromida i kombinacije formoterola
GB201520862D0 (en) * 2015-11-25 2016-01-13 Jagotec Ag Pharmaceutical composition
WO2017108917A1 (en) * 2015-12-22 2017-06-29 Astrazeneca Ab Pharmaceutical compositions for use in the treatment of chronic obstructive pulmonary disease
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EP3515432B1 (en) 2016-09-19 2021-08-25 Mexichem Fluor S.A. de C.V. Pharmaceutical composition comprising glycopyrrolate
CN114206317A (zh) * 2019-07-12 2022-03-18 金德瓦药物控释有限公司 气雾剂制剂、含有该制剂的罐和吸入器以及使用方法
WO2021033081A1 (en) * 2019-08-16 2021-02-25 Glenmark Pharmaceutical Limited Stable aerosol composition for inhalation comprising glycopyrronium, formoterol and corticosteroid
CN112438966B (zh) * 2019-08-30 2022-08-26 四川普锐特药业有限公司 一种医用定量吸入气雾剂
IL293328A (en) 2019-12-02 2022-07-01 Chiesi Farm Spa Stainless steel canister for pressurized metered dose inhalers
WO2021138386A1 (en) * 2020-01-04 2021-07-08 Cai Gu Huang Propellant-free formulation for inhalation
MX2022008440A (es) * 2020-01-28 2022-08-02 Chiesi Farm Spa Inhaladores de dosis medida presurizada que comprenden una formulacion farmaceutica amortiguada.
GB2593970A (en) * 2020-02-20 2021-10-13 Chiesi Farm Spa Pressurised metered dose inhalers comprising a buffered pharmaceutical formulation
EP4188327A1 (en) 2020-07-31 2023-06-07 Chemo Research, S.L. Combination therapy for inhalation administration

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SG11201605311UA (en) * 2013-12-30 2016-07-28 Chiesi Farma Spa Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination

Also Published As

Publication number Publication date
HRP20180944T1 (hr) 2018-08-10
TR201809356T4 (tr) 2018-07-23
NO3096737T3 (es) 2018-09-01
CN113143894A (zh) 2021-07-23
US20170095444A1 (en) 2017-04-06
IL246502B (en) 2020-05-31
GEP20186870B (en) 2018-06-25
SA516371428B1 (ar) 2018-09-30
AU2014375300B2 (en) 2019-10-24
LT3096737T (lt) 2018-06-11
AR098983A1 (es) 2016-06-22
PT3096737T (pt) 2018-04-27
MY176191A (en) 2020-07-24
JP2019112458A (ja) 2019-07-11
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UA117846C2 (uk) 2018-10-10
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EP3096737A1 (en) 2016-11-30
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PH12016501269A1 (en) 2016-08-15
EA201691127A1 (ru) 2016-12-30
US10617669B2 (en) 2020-04-14
RS57269B1 (sr) 2018-08-31
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CA2935302A1 (en) 2015-07-09
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BR112016014586A2 (pt) 2017-08-08
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SG11201605309UA (en) 2016-07-28
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PH12016501269B1 (en) 2016-08-15
HUE039359T2 (hu) 2018-12-28
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