RU2016109632A - Способы и композиции для лечения абстинентных синдромов с использованием неседативных трансдермальных композиций на основе дексмедетомидина - Google Patents
Способы и композиции для лечения абстинентных синдромов с использованием неседативных трансдермальных композиций на основе дексмедетомидина Download PDFInfo
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- RU2016109632A RU2016109632A RU2016109632A RU2016109632A RU2016109632A RU 2016109632 A RU2016109632 A RU 2016109632A RU 2016109632 A RU2016109632 A RU 2016109632A RU 2016109632 A RU2016109632 A RU 2016109632A RU 2016109632 A RU2016109632 A RU 2016109632A
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- dexmedetomidine
- subject
- withdrawal
- withdrawal syndrome
- includes delivering
- Prior art date
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- 238000000034 method Methods 0.000 title claims 16
- HRLIOXLXPOHXTA-NSHDSACASA-N dexmedetomidine Chemical compound C1([C@@H](C)C=2C(=C(C)C=CC=2)C)=CN=C[N]1 HRLIOXLXPOHXTA-NSHDSACASA-N 0.000 title claims 11
- 229960004253 dexmedetomidine Drugs 0.000 title claims 11
- 239000000203 mixture Substances 0.000 title claims 4
- 208000011580 syndromic disease Diseases 0.000 title 1
- 208000007271 Substance Withdrawal Syndrome Diseases 0.000 claims 13
- 206010048010 Withdrawal syndrome Diseases 0.000 claims 7
- 239000000932 sedative agent Substances 0.000 claims 6
- 230000001624 sedative effect Effects 0.000 claims 6
- 230000037317 transdermal delivery Effects 0.000 claims 4
- SVUOLADPCWQTTE-UHFFFAOYSA-N 1h-1,2-benzodiazepine Chemical compound N1N=CC=CC2=CC=CC=C12 SVUOLADPCWQTTE-UHFFFAOYSA-N 0.000 claims 2
- 206010053164 Alcohol withdrawal syndrome Diseases 0.000 claims 2
- 208000026251 Opioid-Related disease Diseases 0.000 claims 2
- 208000029650 alcohol withdrawal Diseases 0.000 claims 2
- 229940049706 benzodiazepine Drugs 0.000 claims 2
- 201000005040 opiate dependence Diseases 0.000 claims 2
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 claims 1
- 244000025254 Cannabis sativa Species 0.000 claims 1
- 235000012766 Cannabis sativa ssp. sativa var. sativa Nutrition 0.000 claims 1
- 235000012765 Cannabis sativa ssp. sativa var. spontanea Nutrition 0.000 claims 1
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims 1
- 238000004026 adhesive bonding Methods 0.000 claims 1
- 229960002715 nicotine Drugs 0.000 claims 1
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 claims 1
- 239000011241 protective layer Substances 0.000 claims 1
- 229920002554 vinyl polymer Polymers 0.000 claims 1
Classifications
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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
- A61K31/41—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
- A61K31/415—1,2-Diazoles
-
- 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
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
-
- 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
- A61K31/4164—1,3-Diazoles
- A61K31/417—Imidazole-alkylamines, e.g. histamine, phentolamine
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/34—Tobacco-abuse
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Addiction (AREA)
- Psychiatry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (20)
1. Способ лечения абстинентного синдрома у субъекта, включающий нанесение на поверхность кожи неседированного субъекта, у которого диагностирован абстинентный синдром, устройства для трансдермальной доставки, содержащего:
композицию на основе дексмедетомидина, которая содержит:
дексмедетомидин; и
клей, склеивающий при надавливании; и
защитный слой,
причем композиция на основе дексмедетомидина составлена так, чтобы доставлять неседативное количество дексмедетомидина для лечения абстинентного синдрома у субъекта.
2. Способ по п. 1, отличающийся тем, что абстинентный синдром выбран из группы, состоящей из алкогольного абстинентного синдрома, бензодиазепинового абстинентного синдрома, опиоидной зависимости, абстинентного синдрома от марихуаны, абстинентного синдрома у новорожденных, никотинового абстинентного синдрома и абстинентного синдрома от антидепрессантов.
3. Способ по п. 2, отличающийся тем, что абстинентный синдром представляет собой опиоидную зависимость.
4. Способ по п. 2, отличающийся тем, что абстинентный синдром представляет собой алкогольный абстинентный синдром.
5. Способ по п. 2, отличающийся тем, что абстинентный синдром представляет собой бензодиазепиновый абстинентный синдром.
6. Способ по п. 1, отличающийся тем, что включает доставку субъекту неседативного количества дексмедетомидина в течение 1 дня или более.
7. Способ по п. 1, отличающийся тем, что включает доставку субъекту неседативного количества дексмедетомидина в течение 3 дней или более.
8. Способ по п. 1, отличающийся тем, что включает доставку субъекту неседативного количества дексмедетомидина в течение 7 дней или более.
9. Способ по п. 1, отличающийся тем, что включает доставку субъекту неседативного количества дексмедетомидина таким образом, чтобы показатель шкалы Рамсея для субъекта составлял не более 3 баллов.
10. Способ по п. 1, отличающийся тем, что включает доставку субъекту неседативного количества дексмедетомидина таким образом, чтобы показатель шкалы Рамсея для субъекта составлял не более 2 баллов.
11. Способ по п. 1, отличающийся тем, что субъект активен и способен реагировать на устные команды.
12. Способ по п. 1, отличающийся тем, что включает доставку субъекту дексмедетомидина с помощью устройства для трансдермальной доставки со скоростью, которая изменяется от около 5 мкг/сутки до около 500 мкг/сутки.
13. Способ по п. 1, отличающийся тем, что клей, склеивающий при надавливании, содержит виниловый полимер.
14. Устройство для трансдермальной доставки, для применения в способе по любому из пп. 1-13.
15. Набор, содержащий два или более устройства для трансдермальной доставки, для применения в способе по любому из пп. 1-13.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361887871P | 2013-10-07 | 2013-10-07 | |
US61/887,871 | 2013-10-07 | ||
PCT/US2014/059058 WO2015054063A1 (en) | 2013-10-07 | 2014-10-03 | Methods and compositions for treating withdrawal syndromes using non-sedative dexmedetomidine transdermal compositions |
Publications (2)
Publication Number | Publication Date |
---|---|
RU2016109632A true RU2016109632A (ru) | 2017-11-15 |
RU2648817C2 RU2648817C2 (ru) | 2018-03-28 |
Family
ID=52777130
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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RU2016109632A RU2648817C2 (ru) | 2013-10-07 | 2014-10-03 | Способы и композиции для лечения абстинентных синдромов с использованием неседативных трансдермальных композиций на основе дексмедетомидина |
Country Status (10)
Country | Link |
---|---|
US (1) | US20150098983A1 (ru) |
EP (1) | EP3054934B1 (ru) |
JP (1) | JP6231670B2 (ru) |
KR (2) | KR20160055934A (ru) |
CN (1) | CN105682650B (ru) |
CA (1) | CA2924190C (ru) |
FI (1) | FI3054934T3 (ru) |
RU (1) | RU2648817C2 (ru) |
TW (1) | TWI624278B (ru) |
WO (1) | WO2015054063A1 (ru) |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2015054059A2 (en) * | 2013-10-07 | 2015-04-16 | Teikoku Pharma Usa, Inc. | Methods and compositions for treating attention deficit hyperactivity disorder, anxiety and insomnia using dexmedetomidine transdermal compositions |
GB201600918D0 (en) * | 2016-01-18 | 2016-03-02 | Buzzz Pharmaceuticals Ltd | Transdermal patch |
EP3532038A4 (en) * | 2016-10-31 | 2020-06-03 | Teikoku Pharma USA, Inc. | METHOD FOR MANAGING PAIN BY MEANS OF DEVMEDETOMIDINE TRANSDERMAL ADMINISTRATION DEVICES |
KR20240031326A (ko) | 2016-12-31 | 2024-03-07 | 바이오엑셀 테라퓨틱스 인코포레이티드 | 불안의 치료를 위한 설하 덱스메데토미딘의 용도 |
CN111447927A (zh) * | 2017-12-08 | 2020-07-24 | 帝国制药美国公司 | 纳洛酮经皮给药装置及其使用方法 |
MX2020014000A (es) | 2018-06-27 | 2021-06-15 | Bioxcel Therapeutics Inc | Formulaciones en lámina que contienen dexmedetomidina y métodos para producirlas. |
US20210267944A1 (en) | 2018-06-27 | 2021-09-02 | Bioxcel Therapeutics, Inc. | Methods for treating agitation using dexmedetomidine hydrochloride |
EP3723740A1 (en) | 2018-10-15 | 2020-10-21 | Vardi, Amnon | Slow release cannabinoids and products thereof |
MX2021004737A (es) * | 2018-10-24 | 2021-06-04 | Saniona As | Composiciones de tropano transdermicas y metodos para usar las mismas. |
CN113710238A (zh) * | 2019-04-17 | 2021-11-26 | Lts勒曼治疗系统股份公司 | 透皮治疗系统 |
MX2022000709A (es) * | 2019-07-19 | 2022-05-19 | Bioxcel Therapeutics Inc | Regimenes de tratamiento con dexmedetomidina no sedante. |
WO2022076818A1 (en) * | 2020-10-08 | 2022-04-14 | Bioxcel Therapeutics, Inc. | Treatment of bipolar disorders and psychosis using dexmedetomidine hydrochloride |
US20220226288A1 (en) * | 2021-01-04 | 2022-07-21 | Bioxcel Therapeutics, Inc. | Dexmedetomidine treatment regimens |
US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
Family Cites Families (17)
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US5217718A (en) * | 1989-08-18 | 1993-06-08 | Cygnus Therapeutic Systems | Method and device for administering dexmedetomidine transdermally |
US5124157A (en) * | 1989-08-18 | 1992-06-23 | Cygnus Therapeutic Systems | Method and device for administering dexmedetomidine transdermally |
GB9111732D0 (en) * | 1991-05-31 | 1991-07-24 | Orion Yhtymae Oy | The use of certain salts of medetomidine and its optically active enantiomers to regulate the rate of transdermal administration of the drugs |
HU228434B1 (en) * | 1995-06-07 | 2013-03-28 | Ortho Mcneil Pharm Inc | Transdermal medicament for administering 17-deacetyl norgestimate alone or in combination with an estrogen |
GB9521680D0 (en) * | 1995-10-23 | 1996-01-03 | Orion Yhtymo Oy | New use of imidazole derivatives |
US5891868A (en) * | 1997-11-21 | 1999-04-06 | Kaiser Foundation Health Plan, Inc. | Methods for treating postmenopausal women using ultra-low doses of estrogen |
PT1117390E (pt) * | 1998-10-02 | 2005-01-31 | 3M Innovative Properties Co | Sistemas de distribuicao de farmacos originarios da mucosa e aplicacoes em animais |
US20030170195A1 (en) * | 2000-01-10 | 2003-09-11 | Noven Pharmaceuticals, Inc. | Compositions and methods for drug delivery |
US20060240086A1 (en) * | 2003-07-31 | 2006-10-26 | Tetsuro Tateishi | Adhesive patch |
KR101426364B1 (ko) * | 2006-09-11 | 2014-08-05 | 세키스이가가쿠 고교가부시키가이샤 | 첩부제 |
EP2286814B1 (en) * | 2008-05-15 | 2013-10-16 | Hisamitsu Pharmaceutical Co., Inc. | Transdermal preparation containing palonosetron |
NZ601195A (en) * | 2010-01-08 | 2015-02-27 | Recro Pharma Inc | Topical transdermal dexmedetomidine compositions and methods of use thereof |
CN103200944B (zh) * | 2010-11-17 | 2016-05-04 | 赫克萨尔股份公司 | 包含丁丙诺啡的经皮治疗系统 |
WO2013072763A2 (en) * | 2011-11-16 | 2013-05-23 | Nometics Inc. | Non-sensitizing transdermal clonidine patch |
EP2787970B1 (en) * | 2011-12-11 | 2018-04-11 | Recro Pharma, Inc. | Intranasal dexmedetomidine compositions and methods of use thereof |
US8242158B1 (en) * | 2012-01-04 | 2012-08-14 | Hospira, Inc. | Dexmedetomidine premix formulation |
WO2013113690A1 (en) * | 2012-01-31 | 2013-08-08 | Grünenthal GmbH | Pharmaceutical patch for transdermal administration of (1r,4r)-6'-fluoro-n,n-dimethyl-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexane-1,1'-pyrano[3,4-b]indol]-4-amine |
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2014
- 2014-10-03 EP EP14852359.0A patent/EP3054934B1/en active Active
- 2014-10-03 CA CA2924190A patent/CA2924190C/en active Active
- 2014-10-03 US US14/505,943 patent/US20150098983A1/en not_active Abandoned
- 2014-10-03 CN CN201480058703.8A patent/CN105682650B/zh active Active
- 2014-10-03 RU RU2016109632A patent/RU2648817C2/ru active
- 2014-10-03 KR KR1020167010340A patent/KR20160055934A/ko active Application Filing
- 2014-10-03 JP JP2016520591A patent/JP6231670B2/ja active Active
- 2014-10-03 WO PCT/US2014/059058 patent/WO2015054063A1/en active Application Filing
- 2014-10-03 TW TW103134526A patent/TWI624278B/zh active
- 2014-10-03 KR KR1020187004780A patent/KR101881791B1/ko active IP Right Grant
- 2014-10-03 FI FIEP14852359.0T patent/FI3054934T3/fi active
Also Published As
Publication number | Publication date |
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KR101881791B1 (ko) | 2018-07-25 |
US20150098983A1 (en) | 2015-04-09 |
KR20160055934A (ko) | 2016-05-18 |
JP2016532643A (ja) | 2016-10-20 |
EP3054934A1 (en) | 2016-08-17 |
JP6231670B2 (ja) | 2017-11-15 |
BR112016006200A2 (pt) | 2017-08-01 |
CN105682650B (zh) | 2020-09-25 |
KR20180021902A (ko) | 2018-03-05 |
TWI624278B (zh) | 2018-05-21 |
RU2648817C2 (ru) | 2018-03-28 |
CN105682650A (zh) | 2016-06-15 |
CA2924190A1 (en) | 2015-04-16 |
EP3054934B1 (en) | 2024-05-22 |
CA2924190C (en) | 2019-07-09 |
WO2015054063A1 (en) | 2015-04-16 |
EP3054934A4 (en) | 2017-04-05 |
FI3054934T3 (fi) | 2024-07-19 |
TW201521799A (zh) | 2015-06-16 |
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