HRP20151214T4 - Pripravak za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne plućne bolesti - Google Patents
Pripravak za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne plućne bolesti Download PDFInfo
- Publication number
- HRP20151214T4 HRP20151214T4 HRP20151214TT HRP20151214T HRP20151214T4 HR P20151214 T4 HRP20151214 T4 HR P20151214T4 HR P20151214T T HRP20151214T T HR P20151214TT HR P20151214 T HRP20151214 T HR P20151214T HR P20151214 T4 HRP20151214 T4 HR P20151214T4
- Authority
- HR
- Croatia
- Prior art keywords
- aclidinium
- pharmaceutical composition
- pharmaceutically acceptable
- acceptable salt
- use according
- Prior art date
Links
- ASMXXROZKSBQIH-VITNCHFBSA-N aclidinium Chemical compound C([C@@H](C(CC1)CC2)OC(=O)C(O)(C=3SC=CC=3)C=3SC=CC=3)[N+]21CCCOC1=CC=CC=C1 ASMXXROZKSBQIH-VITNCHFBSA-N 0.000 title claims 22
- 229940019903 aclidinium Drugs 0.000 title claims 16
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 title claims 4
- 239000000203 mixture Substances 0.000 title claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 11
- 150000003839 salts Chemical class 0.000 claims 8
- 229960005012 aclidinium bromide Drugs 0.000 claims 6
- 239000000843 powder Substances 0.000 claims 5
- 239000013543 active substance Substances 0.000 claims 4
- 229940124748 beta 2 agonist Drugs 0.000 claims 2
- 239000003246 corticosteroid Substances 0.000 claims 2
- 229960001334 corticosteroids Drugs 0.000 claims 2
- 229960000289 fluticasone propionate Drugs 0.000 claims 2
- WMWTYOKRWGGJOA-CENSZEJFSA-N fluticasone propionate Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(OC(=O)CC)[C@@]2(C)C[C@@H]1O WMWTYOKRWGGJOA-CENSZEJFSA-N 0.000 claims 2
- 229960002848 formoterol Drugs 0.000 claims 2
- BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 2
- 239000002587 phosphodiesterase IV inhibitor Substances 0.000 claims 2
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 claims 1
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims 1
- GIIZNNXWQWCKIB-UHFFFAOYSA-N Serevent Chemical compound C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1 GIIZNNXWQWCKIB-UHFFFAOYSA-N 0.000 claims 1
- 230000004913 activation Effects 0.000 claims 1
- 229960004436 budesonide Drugs 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 229940112141 dry powder inhaler Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 229960004017 salmeterol Drugs 0.000 claims 1
- 229940021615 salmeterol and budesonide Drugs 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
- A61K31/435—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
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- 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
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- 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
- A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- 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
- 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
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- 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
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Emergency Medicine (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (13)
1. Farmaceutski sastav koji sadrži aklidinij u obliku suhog praha farmaceutski prihvatljive soli u mješavini s farmaceutski prihvatljivim nosačem suhog praha, omogućava izmjerenu nominalnu dozu ekvivalenta aklidiniju do 400 µg (plus/minus 10%) aklidinij bromida za upotrebu udisanjem kod liječenja kronične opstruktivne bolesti pluća.
2. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 1, u obliku jednodozne formulacije suhog praha koja sadrži jednu izmjerenu nominalnu dozu aklidinija ekvivalentnu 400 mikrograma (plus/minus 10%) aklidinij bromida.
3. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 1, u obliku višedozne formulacije suhog praha za primjenu u višedoznom uređaju za inhalaciju suhog praha kalibriranom da osigura izmjerenu nominalnu dozu aklidinija koja je jednaka 400 mikrograma (plus/minus 10%) aklidinij bromida.
4. Farmaceutski sastav za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva gdje (a) farmaceutski prihvatljiva sol aklidinija je aklidinij bromid, i/ili (b) farmaceutski prihvatliv nosač su čestice laktoze.
5. Farmaceutski sastav za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, gdje je odnos težine aklidinija prema nosaču od 1:25 do 1:75.
6. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 5, gdje je odnos težine aklidinija prema nosaču od 1:50 do 1:75.
7. Farmaceutski sastav za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, gdje farmaceutski sastav još sadrži djelotvornu količinu jednog ili više dodatnih aktivnih agenasa izabranih iz β2-agonista, PDE IV inhibitora, i kortikosteroida.
8. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 7 gdje se dodatni aktivni agens bira iz: (i) formoterola, salmeterola i budesonida, u slobodnom ili u obliku farmaceutski prihvatljive soli, i (ii) flutikazon propionata.
9. Aklidinij u obliku farmaceutski prihvatljive soli za upotrebu u liječenju kronične opstruktivne bolesti pluća kod pacijenta kome je potrebno takvo liječenje, spomenuta upotreba obuhvaća primjenu udisanjem jednom ili dvaput dnevno izmjerene nominalne doze aklidinija koja odgovara količini od 400 µg (plus/minus 10%) aklidinij bromida, u obliku farmaceutskog sastava prema bilo kojem patentnom zahtjevu 1 do 8.
10. Aklidinij u obliku farmaceutski prihvatljive soli za upotrebu prema patentnom zahtjevu 9, spomenuta upotreba još sadrži primjenu djelotvorne količine jednog ili više aktivnih agenasa koji se biraju iz grupe β2-agonista, PDE IV inhibitora i kortikosteroida.
11. Aklidinij u obliku farmaceutski prihvatljive soli za upotrebu prema patentnom zahtjevu 10, gdje se dodatni aktivni agens bira iz: (i) formoterola, salmeterola, i budesonida, u slobodnom obliku ili u obliku farmaceutski prihvatljive soli, i (ii) flutikazon propionata.
12. Upotreba aklidinija u obliku farmaceutski prihvatljive soli za proizvodnju lijeka za liječenje kronične opstruktivne bolesti pluća kod pacijenta kome je potrebno takvo liječenje, spomenuta upotreba obuhvaća primjenu udisanjem jednom ili dvaput dnevno izmjerene nominalne doze aklidinijuma koja odgovara količini od 400 µg (plus/minus 10%) aklidinim bromida, u obliku farmaceutskog sastava prema bilo kojem patentnom zahtjevu 1 do 8.
13. Uređaj za udisanje suhog praha u vidu više doza sadrži aklidinijm, koji se kalibrira da isporuči, poslije aktiviranja, izmjerenu nominalnu dozu aklidinija ekvivalentnu količini 400 mikrograma (plus/minus 10%) aklidinij bromida.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08382010A EP2100599A1 (en) | 2008-03-13 | 2008-03-13 | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
EP09719213.2A EP2265257B2 (en) | 2008-03-13 | 2009-03-13 | Inhalation composition containing aclidinium for treatment of chronic obstructive pulmonary disease |
PCT/EP2009/001832 WO2009112274A2 (en) | 2008-03-13 | 2009-03-13 | Novel dosage and formulation |
Publications (2)
Publication Number | Publication Date |
---|---|
HRP20151214T1 HRP20151214T1 (hr) | 2015-12-18 |
HRP20151214T4 true HRP20151214T4 (hr) | 2024-01-05 |
Family
ID=39645012
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20220929TT HRP20220929T3 (hr) | 2008-03-13 | 2009-03-13 | Sastav za inhalaciju koji sadrži aklidinij za liječenje astme |
HRP20220919TT HRP20220919T3 (hr) | 2008-03-13 | 2009-03-13 | Sastav za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne bolesti pluća |
HRP20151214TT HRP20151214T4 (hr) | 2008-03-13 | 2009-03-13 | Pripravak za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne plućne bolesti |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20220929TT HRP20220929T3 (hr) | 2008-03-13 | 2009-03-13 | Sastav za inhalaciju koji sadrži aklidinij za liječenje astme |
HRP20220919TT HRP20220919T3 (hr) | 2008-03-13 | 2009-03-13 | Sastav za inhalaciju koji sadrži aklidinij za liječenje kronične opstruktivne bolesti pluća |
Country Status (37)
Country | Link |
---|---|
US (3) | US20110020412A1 (hr) |
EP (5) | EP2100599A1 (hr) |
JP (3) | JP2011513451A (hr) |
KR (3) | KR20180125055A (hr) |
CN (2) | CN102083416A (hr) |
AR (1) | AR070835A1 (hr) |
AU (1) | AU2009224895B9 (hr) |
BR (1) | BRPI0905775B1 (hr) |
CA (1) | CA2716724C (hr) |
CL (1) | CL2009000602A1 (hr) |
CO (1) | CO6290636A2 (hr) |
CY (1) | CY1116926T1 (hr) |
DK (3) | DK2265257T4 (hr) |
EC (1) | ECSP10010300A (hr) |
ES (3) | ES2551307T5 (hr) |
FI (1) | FI2265257T4 (hr) |
HK (1) | HK1145815A1 (hr) |
HR (3) | HRP20220929T3 (hr) |
HU (3) | HUE027726T2 (hr) |
IL (3) | IL206354A0 (hr) |
LT (2) | LT2954891T (hr) |
ME (1) | ME02286B (hr) |
MX (2) | MX2010008235A (hr) |
MY (1) | MY177027A (hr) |
NZ (1) | NZ585857A (hr) |
PE (3) | PE20190406A1 (hr) |
PL (3) | PL2954889T3 (hr) |
PT (3) | PT2954889T (hr) |
RS (3) | RS54241B2 (hr) |
RU (3) | RU2608713C3 (hr) |
SG (1) | SG188825A1 (hr) |
SI (3) | SI2954891T1 (hr) |
TW (1) | TWI439296B (hr) |
UA (1) | UA101652C2 (hr) |
UY (1) | UY31687A1 (hr) |
WO (1) | WO2009112274A2 (hr) |
ZA (1) | ZA201003900B (hr) |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2165768B1 (es) | 1999-07-14 | 2003-04-01 | Almirall Prodesfarma Sa | Nuevos derivados de quinuclidina y composiciones farmaceuticas que los contienen. |
ES2298049B1 (es) | 2006-07-21 | 2009-10-20 | Laboratorios Almirall S.A. | Procedimiento para fabricar bromuro de 3(r)-(2-hidroxi-2,2-ditien-2-ilacetoxi)-1-(3-fenoxipropil)-1-azoniabiciclo (2.2.2) octano. |
EP2100599A1 (en) | 2008-03-13 | 2009-09-16 | Laboratorios Almirall, S.A. | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
EP2100598A1 (en) | 2008-03-13 | 2009-09-16 | Laboratorios Almirall, S.A. | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
EP2510928A1 (en) * | 2011-04-15 | 2012-10-17 | Almirall, S.A. | Aclidinium for use in improving the quality of sleep in respiratory patients |
EP2666465A1 (en) * | 2012-05-25 | 2013-11-27 | Almirall, S.A. | Novel dosage and formulation |
EA201590019A1 (ru) * | 2012-07-05 | 2015-09-30 | Арвен Айлак Санайи Ве Тиджарет А.С. | Ингаляторы сухого порошка, содержащие носитель, отличный от лактозы |
US10105316B2 (en) | 2012-07-05 | 2018-10-23 | Arven llac Sanayi Ve Ticaret A.S. | Inhalation compositions comprising muscarinic receptor antagonist |
EA201590030A1 (ru) * | 2012-07-05 | 2015-09-30 | Арвен Айлак Санайи Ве Тиджарет А.С. | Ингаляторы сухого порошка, содержащие носитель, отличный от лактозы, и третий компонент |
US10111957B2 (en) | 2012-07-05 | 2018-10-30 | Arven Ilac Snayi ve Ticaret A.S. | Inhalation compositions comprising glucose anhydrous |
ES2917879T3 (es) * | 2012-12-17 | 2022-07-12 | Almirall Sa | Nuevo uso de aclidinio |
AU2014261539A1 (en) * | 2013-04-29 | 2015-12-10 | Sanofi Sa | Inhalable pharmaceutical compositions and the inhaler devices containing them |
EP2923702A1 (en) * | 2014-03-28 | 2015-09-30 | Universite De Liege | Composition of cyclodextrin with budesonide derivatives for treatment and prevention of pulmonary inflammatory disease |
US10864213B2 (en) | 2014-05-12 | 2020-12-15 | Verona Pharma Plc | Treatment |
CZ2015257A3 (cs) * | 2015-04-16 | 2016-10-26 | Zentiva, K.S. | Způsob pro zmenšování velikosti částic bromidu [(3R)-1-(3-fenoxypropyl)chinuklidin-1-ium-3-yl] 2-hydroxy-2,2-bis(2-thienyl)acetátu |
CN107823193B (zh) * | 2017-11-16 | 2021-02-05 | 广州迈达康医药科技有限公司 | 一种阿地溴铵吸入型粉雾剂及其制备方法 |
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EP2100598A1 (en) † | 2008-03-13 | 2009-09-16 | Laboratorios Almirall, S.A. | Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease |
EP2510928A1 (en) | 2011-04-15 | 2012-10-17 | Almirall, S.A. | Aclidinium for use in improving the quality of sleep in respiratory patients |
EP2666465A1 (en) | 2012-05-25 | 2013-11-27 | Almirall, S.A. | Novel dosage and formulation |
ES2917879T3 (es) | 2012-12-17 | 2022-07-12 | Almirall Sa | Nuevo uso de aclidinio |
WO2014096553A1 (en) | 2012-12-21 | 2014-06-26 | Intellipocket Oy | Generating a customized application |
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