DK2985025T3 - Farmaceutisk sammensætning - Google Patents

Farmaceutisk sammensætning Download PDF

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Publication number
DK2985025T3
DK2985025T3 DK15179438.5T DK15179438T DK2985025T3 DK 2985025 T3 DK2985025 T3 DK 2985025T3 DK 15179438 T DK15179438 T DK 15179438T DK 2985025 T3 DK2985025 T3 DK 2985025T3
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compound
treatment
patients
pharmaceutically acceptable
combination
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DK15179438.5T
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Inventor
Martin Friedrich Stefanic
Frank Hilberg
Rolf Kaiser
David Shapiro
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Boehringer Ingelheim Int
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Cardiology (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pathology (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oncology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Reproductive Health (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Transplantation (AREA)

Claims (11)

1. Farmaceutisk kombination omfattende forbindelsen 3-Z-[l-(4-(/V-((4-methylpiperazin-l-yl)methylcarbonyl)-/V-methylamino)-anilino)-l-phenyl-methylen]-6-methoxycarbonyl-2-indolinon eller et farmaceutisk acceptabelt salt deraf og forbindelsen /V-[4-[2-(2-amino-4,7-dihydro-4-oxo-l/-/-pyrrolo[2,3-c/]pyrimidin-5-yl)ethyl]benzoyl]-L-glutaminsyre eller et farmaceutisk acceptabelt salt deraf til anvendelse i en fremgangsmåde til behandling af malignt pleural eller peritonealt mesotheliom.
2. Farmaceutisk kombination til anvendelse ifølge krav 1, hvor den farmaceutiske kombination er til anvendelse i en fremgangsmåde til behandling af malignt pleural mesotheliom.
3. Farmaceutisk kombination til anvendelse ifølge krav 1 eller 2, hvori det farmaceutisk acceptable salt af forbindelsen 3-Z-[l-(4-(/V-((4-methylpiperazin-l-yl)methylcarbonyl)-/V-methylamino)-anilino)-l-phenylmethylen]-6-methoxycarbonyl-2-indolinon er dens monoethansulfonat-saltform.
4. Farmaceutisk kombination til anvendelse ifølge krav 1 eller 2, hvori det farmaceutisk acceptable salt af forbindelsen /V-[4-[2-(2-amino-4,7-dihydro-4-oxo-l/-/-pyrrolo[2,3-c/]pyrimidin-5-yl)ethyl]benzoyl]-L-glutaminsyre er dens dinatriumsaltform.
5. Farmaceutisk kombination til anvendelse ifølge krav 1 eller 2, omfattende mono-ethansulfonat-saltformen af forbindelsen 3-Z-[l-(4-(/V-((4-methylpiperazin-l-yl)methylcarbonyl)-/V-methylamino)anilino)-l-phenylmethylen]-6-methoxycarbonyl-2-indolinon og dinatriumsaltformen af forbindelsen /V-[4-[2-(2-amino-4,7-dihydro-4 oxo-lH-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutaminsyre.
6. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af kravene 1 til 5, som er i form af et kombineret præparat til samtidig, separat eller sekventiel anvendelse.
7. Farmaceutisk kombination til anvendelse ifølge et hvilket som helst af kravene 1 til 5, som yderligere er tilpasset en sambehandling med strålebehandling.
8. Forbindelsen 3-Z-[l-(4-(/V-((4-methylpiperazin-l-yl)methylcarbonyl)-/V-methylamino)anilino)-l-phenylmethylen]-6-methoxycarbonyl-2-indolinon eller et farmaceutisk acceptabelt salt deraf til anvendelse i en fremgangsmåde til behandling af malignt pleural eller peritonealt mesotheliom omfattende indgivelse til en patient i behov derfor af en virkningsfuld mængde af forbindelsen før, efter eller samtidig med en virkningsfuld mængde af Forbindelsen /V-[4-[2-(2-amino-4,7-dihydro-4-oxo-lH-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutaminsyre eller et farmaceutisk acceptabelt salt deraf.
9. Forbindelse til anvendelse ifølge krav 8, hvor forbindelsen er beregnet til anvendelse i en fremgangsmåde til behandling af malignt pleural mesotheliom.
10. Forbindelse til anvendelse ifølge krav 8 eller 9, hvor det farmaceutisk acceptable salt af forbindelsen 3-Z-[l-(4-(/V-((4-methylpiperazin-l-yl)-methylcarbonyl)-/V-methylamino)-anilino)-l-phenylmethylen]-6-methoxycarbonyl-2-indolinon er dens mono- ethan-sulfonatsalt.
11. Forbindelse til anvendelse ifølge krav 8 eller 9, hvor det farmaceutisk acceptable salt af forbindelsen /V-[4-[2-(2-amino-4,7-dihydro-4-oxo-l/-/-pyrrolo[2, 3-cf]pyrimidin-5-yl)ethyl]benzoyl]-L-glutaminsyre er dens dinatriumsalt.
DK15179438.5T 2008-06-06 2009-06-04 Farmaceutisk sammensætning DK2985025T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08157749 2008-06-06
US7888208P 2008-07-08 2008-07-08
EP09757599.7A EP2293795B1 (en) 2008-06-06 2009-06-04 Pharmaceutical combination

Publications (1)

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DK2985025T3 true DK2985025T3 (da) 2018-03-19

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ID=40912046

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DK15179438.5T DK2985025T3 (da) 2008-06-06 2009-06-04 Farmaceutisk sammensætning
DK09757599.7T DK2293795T3 (da) 2008-06-06 2009-06-04 Farmaceutisk kombination.

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DK09757599.7T DK2293795T3 (da) 2008-06-06 2009-06-04 Farmaceutisk kombination.

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US (5) US20110178099A1 (da)
EP (2) EP2293795B1 (da)
JP (2) JP5993573B2 (da)
KR (1) KR101760657B1 (da)
CN (1) CN102056609B (da)
AR (1) AR072061A1 (da)
AU (1) AU2009254554B2 (da)
CA (1) CA2726644C (da)
CO (1) CO6280488A2 (da)
CY (2) CY1116877T1 (da)
DK (2) DK2985025T3 (da)
EA (1) EA020046B1 (da)
EC (1) ECSP10010716A (da)
ES (2) ES2552238T3 (da)
HK (1) HK1152640A1 (da)
HR (2) HRP20151186T1 (da)
HU (2) HUE025821T2 (da)
IL (1) IL208953B (da)
LT (1) LT2985025T (da)
MA (1) MA32384B1 (da)
ME (1) ME02273B (da)
MX (1) MX338047B (da)
MY (1) MY158929A (da)
NZ (1) NZ588957A (da)
PE (1) PE20100084A1 (da)
PL (2) PL2985025T3 (da)
PT (2) PT2293795E (da)
RS (2) RS57035B1 (da)
SI (2) SI2985025T1 (da)
TW (1) TWI447113B (da)
UA (1) UA102258C2 (da)
UY (1) UY31866A (da)
WO (1) WO2009147218A1 (da)
ZA (1) ZA201007594B (da)

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US20050043233A1 (en) 2003-04-29 2005-02-24 Boehringer Ingelheim International Gmbh Combinations for the treatment of diseases involving cell proliferation, migration or apoptosis of myeloma cells or angiogenesis
PE20060777A1 (es) 2004-12-24 2006-10-06 Boehringer Ingelheim Int Derivados de indolinona para el tratamiento o la prevencion de enfermedades fibroticas
UA107560C2 (uk) * 2008-06-06 2015-01-26 Фармацевтична лікарська форма для негайного вивільнення похідної індолінону
US20170065529A1 (en) 2015-09-09 2017-03-09 Boehringer Ingelheim International Gmbh Pharmaceutical dosage form for immediate release of an indolinone derivative
LT2299987T (lt) * 2008-06-06 2018-05-25 Boehringer Ingelheim International Gmbh Farmacinės vaisto formos kapsulė, apimanti indolinono darinio suspensijos kompoziciją
US20140350022A1 (en) 2013-05-10 2014-11-27 Boehringer Ingelheim International Gmbh Efficacious treatment of NSCLC and predictive clinical marker of the responsiveness of a tumour to a treatment
US20150044288A1 (en) 2013-07-31 2015-02-12 Windward Pharma, Inc. Aerosol tyrosine kinase inhibitor compounds and uses thereof
EP3365180B1 (en) * 2015-10-21 2019-12-18 Capsugel Belgium NV Printing process for oral dosage forms

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Publication number Publication date
ES2662824T3 (es) 2018-04-09
AU2009254554A1 (en) 2009-12-10
US20130237549A1 (en) 2013-09-12
WO2009147218A1 (en) 2009-12-10
CO6280488A2 (es) 2011-05-20
ZA201007594B (en) 2011-07-27
PE20100084A1 (es) 2010-02-05
AU2009254554B2 (en) 2015-08-20
PL2293795T3 (pl) 2016-01-29
DK2293795T3 (da) 2015-10-19
CA2726644A1 (en) 2009-12-10
ME02273B (me) 2016-02-20
ECSP10010716A (es) 2011-02-28
US20110178099A1 (en) 2011-07-21
MA32384B1 (fr) 2011-06-01
EP2985025A1 (en) 2016-02-17
HRP20151186T1 (hr) 2015-12-04
KR101760657B1 (ko) 2017-07-24
RS57035B1 (sr) 2018-05-31
TW201002690A (en) 2010-01-16
MY158929A (en) 2016-11-30
TWI447113B (zh) 2014-08-01
CN102056609B (zh) 2012-12-05
JP2011522008A (ja) 2011-07-28
US20180243308A1 (en) 2018-08-30
EP2293795A1 (en) 2011-03-16
SI2985025T1 (en) 2018-04-30
CY1120505T1 (el) 2019-07-10
EA020046B1 (ru) 2014-08-29
HK1152640A1 (en) 2012-03-09
IL208953A0 (en) 2011-01-31
HRP20180602T1 (hr) 2018-05-18
RS54293B1 (en) 2016-02-29
PT2293795E (pt) 2015-11-17
LT2985025T (lt) 2018-04-10
PT2985025T (pt) 2018-03-15
MX2010012937A (es) 2011-02-25
SI2293795T1 (sl) 2015-12-31
UA102258C2 (en) 2013-06-25
UY31866A (es) 2010-01-29
JP5993573B2 (ja) 2016-09-14
CY1116877T1 (el) 2017-04-05
NZ588957A (en) 2013-03-28
KR20110025172A (ko) 2011-03-09
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AR072061A1 (es) 2010-08-04
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JP2015007143A (ja) 2015-01-15
CN102056609A (zh) 2011-05-11
HUE037291T2 (hu) 2018-08-28
US20160250218A1 (en) 2016-09-01
IL208953B (en) 2018-03-29
PL2985025T3 (pl) 2018-06-29
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