DK3003383T3 - Fast sammensætning til oral administration indeholdende ibandronsyre eller et farmaceutisk acceptabelt salt deraf og d-vitamin - Google Patents
Fast sammensætning til oral administration indeholdende ibandronsyre eller et farmaceutisk acceptabelt salt deraf og d-vitamin Download PDFInfo
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- DK3003383T3 DK3003383T3 DK14730606.2T DK14730606T DK3003383T3 DK 3003383 T3 DK3003383 T3 DK 3003383T3 DK 14730606 T DK14730606 T DK 14730606T DK 3003383 T3 DK3003383 T3 DK 3003383T3
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- oral administration
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- 150000002816 nickel compounds Chemical class 0.000 description 1
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- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000003605 opacifier Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
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- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
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- 235000010265 sodium sulphite Nutrition 0.000 description 1
- VBDRTGFACFYFCT-UHFFFAOYSA-M sodium;hydroxy-[(1r)-1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphinate;hydrate Chemical compound O.[Na+].CCCCCN(C)CCC(O)(P(O)(O)=O)P(O)([O-])=O VBDRTGFACFYFCT-UHFFFAOYSA-M 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- TUNFSRHWOTWDNC-HKGQFRNVSA-N tetradecanoic acid Chemical compound CCCCCCCCCCCCC[14C](O)=O TUNFSRHWOTWDNC-HKGQFRNVSA-N 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- JEJAMASKDTUEBZ-UHFFFAOYSA-N tris(1,1,3-tribromo-2,2-dimethylpropyl) phosphate Chemical compound BrCC(C)(C)C(Br)(Br)OP(=O)(OC(Br)(Br)C(C)(C)CBr)OC(Br)(Br)C(C)(C)CBr JEJAMASKDTUEBZ-UHFFFAOYSA-N 0.000 description 1
- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 description 1
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- 230000004580 weight loss Effects 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
Classifications
-
- 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
- A61K31/66—Phosphorus compounds
- A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
- A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
-
- 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
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61K9/2893—Tablet coating processes
-
- 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
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- 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
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Physical Education & Sports Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Biophysics (AREA)
- Molecular Biology (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 (19)
1. Fast farmaceutisk sammensætning til oral administration til anvendelse i behandlingen af knoglesygdomme omfattende ibandronsyre eller et farmaceutisk acceptabelt salt, D-vitamin, i tæt sammenblanding med mellemkæde-triglycerider eller en hydrogeneret olie.
2. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge krav 1, hvor ibandronsyre eller et farmaceutisk acceptabelt salt deraf er til stede i en mængde på 50 mg til 200 mg.
3. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge kravene 1 og 2, hvor D-vitamin er til stede i en mængde på 11000 IU til 44800 IU.
4. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge kravene 1 til 3, hvor den hydrogenerede olie er en fuldstændig hydrogeneret olie eller en delvist hydrogeneret olie.
5. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge kravene 1 til 4, hvor den hydrogenerede olie er en hydrogeneret vegetabilsk olie.
6. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge kravene 4 til 5, hvor den fuldstændigt hydrogenerede olie er valgt fra gruppen bestående af hydrogeneret sojaolie, hydrogeneret bomuldsfrøolie, hydrogeneret castorolie og blandinger deraf.
7. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge kravene 4 til 5, hvor den delvist hydrogenerede olie er valgt fra gruppen bestående af delvist hydrogeneret sojaolie, delvist hydrogeneret bomuldsfrøolie, delvist hydrogeneret castorolie og blandinger deraf.
8. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge et hvilket som helst af de foregående krav, hvor mængden af mellemkæde-triglycerider eller olien (total eller delvist) hydrogeneret er mellem 0,001 til 0,25 dele (i vægt) til en del (i vægt) af ibandronsyre eller et farmaceutisk acceptabelt salt deraf.
9. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge krav 8, hvor mængden af mellemkæde-triglycerider eller den totalt eller delvist hydrogenerede olie er mellem 0,01 til 0,08 dele (i vægt) til en del (i vægt) af ibandronsyre eller et farmaceutisk acceptabelt salt deraf.
10. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge krav 9, hvor, mængden af mellemkæde-triglycerider eller de totalt eller delvist hydrogenerede olier mellem 0,04 til 0,05 dele (i vægt) til en del (i vægt) af ibandronsyre eller et farmaceutisk acceptabelt salt deraf.
11. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge et hvilket som helst af de foregående krav, omfattende yderligere mindst én af excipienserne valgt fra gruppen af fortyndingsmidler, bindemidler, desintegreringsmidler, overfladeaktive stoffer, flydemidler, smøremidler, antioxidanter eller fri radikal-indfangere.
12. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge krav 11, hvor antioxidanterne og fri radikal-indfangerne er valgt fra gruppen bestående af butylhydroxyltoluen, butylhydroxylanisol, citronsyre og citratsalte, salte af askorbinsyre eller askorbat, alpha- tocopherol, natriumacetat, natriumsulfit og organiske forbindelser med thiol-funktion.
13. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge krav 12, hvorthe antioxidanten er valgt fra gruppen bestående af askorbinsyre, askorbatsalte eller alpha-tocopherol.
14. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge et hvilket som helst af de foregående krav, hvor D-vitamin er til stede i formen af cholecalciferol.
15. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge et hvilket som helst af de foregående krav i formen af tabletter, kapsler eller små poser.
16. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge krav 15, i formen af coatede tabletter.
17. Fast farmaceutisk sammensætning til oral administration til anvendelse ifølge et hvilket som helst af de foregående krav, formuleret til en månedlig administration.
18. Fremgangsmåde til at opnå en fast farmaceutisk sammensætning til oral administration omfattende ibandronsyre eller et farmaceutisk acceptabelt salt, D-vitamin, i tæt sammenblanding med mellemkæde-triglycerider eller en hydrogeneret olie omfattende: - en initial blanding af ibandronsyre eller et farmaceutisk acceptabelt salt deraf med en passende mængde af excipienser under anvendelse af en egnet og konventionel blander - vådgranulering af den forrige blanding under anvendelse af et granuleringsudstyr (en flu id lejetørrer) - tørring af granulater - kalibrering af de tørrede granulater under anvendelse af en egnet og konventionel si - tilsætning af excipienserne præsenteret i den eksterne fase, hvor mellemkæde-triglyceridet eller, en totalt eller delvist hydrogeneret olie inkluderes for at forbedre sammensætningens flydeevnerne, komprimeringsevne og afsættelsesevne - blanding af de tørrede granulater med den eksterne fase under anvendelse afen egnet blander - ved hjælp afen tablettrykmaskine, komprimering af den forrige blanding til kerner eller alternativt, under anvendelse af en påfyldningsmaskine til opnåelsen af kapsler eller små poser.
19. Fremgangsmåde til at opnå en fast farmaceutisk sammensætning til oral administration ifølge krav 18, hvor tabletterne efterfølgende coates.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PT106978A PT106978A (pt) | 2013-05-31 | 2013-05-31 | Composição sólida oral contendo ácido ibandrónico e vitamina d |
| PCT/PT2014/000036 WO2014193255A1 (en) | 2013-05-31 | 2014-05-30 | Solid composition for oral administration containing ibandronic acid or a pharmaceutically acceptable salt thereof and vitamin d |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3003383T3 true DK3003383T3 (da) | 2019-01-28 |
Family
ID=50943510
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14730606.2T DK3003383T3 (da) | 2013-05-31 | 2014-05-30 | Fast sammensætning til oral administration indeholdende ibandronsyre eller et farmaceutisk acceptabelt salt deraf og d-vitamin |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US20160106766A1 (da) |
| EP (1) | EP3003383B1 (da) |
| BR (1) | BR112015029897A2 (da) |
| CL (1) | CL2015003468A1 (da) |
| DK (1) | DK3003383T3 (da) |
| ES (1) | ES2705074T3 (da) |
| HU (1) | HUE040666T2 (da) |
| LT (1) | LT3003383T (da) |
| MA (1) | MA38688B1 (da) |
| MX (1) | MX364680B (da) |
| PL (1) | PL3003383T3 (da) |
| PT (2) | PT106978A (da) |
| RS (1) | RS58133B1 (da) |
| SI (1) | SI3003383T1 (da) |
| TR (1) | TR201821157T4 (da) |
| WO (1) | WO2014193255A1 (da) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK1993559T3 (da) | 2006-02-03 | 2016-10-03 | Opko Renal Llc | Behandling af vitamin D-mangel og -defekt med 25-hydroxyvitamin D2 og 25-hydroxyvitamin D3 |
| ES2670029T3 (es) | 2006-06-21 | 2018-05-29 | Opko Ireland Global Holdings, Ltd. | Terapia usando agente de repleción de la vitamina D y agente de reemplazo de la hormona de la vitamina D |
| DK2481400T3 (da) | 2007-04-25 | 2014-09-29 | Opko Ip Holdings Ii Inc | Orale præparater med kontrolleret frigivelse omfattende en vitamin D-forbindelse og en voksagtig bærer |
| KR101495578B1 (ko) | 2007-04-25 | 2015-02-25 | 사이토크로마 인코포레이티드 | 비타민 ｄ 부족 및 결핍의 치료 방법 |
| CN105796530A (zh) | 2010-03-29 | 2016-07-27 | 赛特克罗公司 | 用于降低甲状旁腺水平的方法和组合物 |
| KR101847947B1 (ko) | 2013-03-15 | 2018-05-28 | 옵코 아이피 홀딩스 Ⅱ 인코포레이티드 | 안정화되고 변형된 비타민 ｄ 방출 제형 |
| US10220047B2 (en) | 2014-08-07 | 2019-03-05 | Opko Ireland Global Holdings, Ltd. | Adjunctive therapy with 25-hydroxyvitamin D and articles therefor |
| IL290855B2 (en) | 2016-03-28 | 2024-06-01 | Eirgen Pharma Ltd | Treatment methods using vitamin D |
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| KR100317935B1 (ko) | 1999-10-20 | 2001-12-22 | 유승필 | 대사성 골질환 치료용 약제조성물 및 이의 제조방법 |
| US6468559B1 (en) * | 2000-04-28 | 2002-10-22 | Lipocine, Inc. | Enteric coated formulation of bishosphonic acid compounds and associated therapeutic methods |
| US20050070504A1 (en) * | 2001-12-21 | 2005-03-31 | The Procter & Gamble Co. | Risedronate compositions and their methods of use |
| WO2003086415A1 (en) | 2002-04-05 | 2003-10-23 | Merck & Co., Inc. | Method for inhibiting bone resorption with an alendronate and vitamin d formulation |
| US20050261250A1 (en) * | 2004-05-19 | 2005-11-24 | Merck & Co., Inc., | Compositions and methods for inhibiting bone resorption |
| US20080139514A1 (en) * | 2006-11-29 | 2008-06-12 | Subhash Pandurang Gore | Diphosphonic acid pharmaceutical compositions |
| US20100179110A1 (en) * | 2006-12-20 | 2010-07-15 | Mostafa Akbarieh | Composition Containing a Bisphosphonic Acid in Combination with Vitamin D |
| EP1972341A1 (en) | 2007-03-23 | 2008-09-24 | Novartis AG | Pharmaceutical compositions comprising a bisphosphonate and vitamin D |
| EP2201937A1 (en) * | 2008-12-23 | 2010-06-30 | Teva Pharmaceutical Industries Ltd. | Formulations comprising vitamin D or derivatives thereof |
| WO2010117346A2 (en) * | 2009-04-10 | 2010-10-14 | Mahmut Bilgic | Stable pharmaceutical compositions with high bioavailibility |
| IT1396937B1 (it) * | 2009-11-26 | 2012-12-20 | Bruzzese | Formulazioni di bisfosfonati e vitamina d idonee alla somministrazione intermittente per via intramuscolare e sottocutanea |
| KR101230178B1 (ko) * | 2010-06-10 | 2013-02-06 | 주식회사 네비팜 | 골다공증 예방 또는 치료용 조성물 및 이의 제조방법 |
| CA2860284C (en) * | 2011-03-02 | 2019-02-05 | D3 Pharma Limited | Vitamin d composition |
-
2013
- 2013-05-31 PT PT106978A patent/PT106978A/pt unknown
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2014
- 2014-05-30 BR BR112015029897A patent/BR112015029897A2/pt not_active Application Discontinuation
- 2014-05-30 SI SI201431025T patent/SI3003383T1/sl unknown
- 2014-05-30 PL PL14730606T patent/PL3003383T3/pl unknown
- 2014-05-30 EP EP14730606.2A patent/EP3003383B1/en active Active
- 2014-05-30 RS RS20181592A patent/RS58133B1/sr unknown
- 2014-05-30 ES ES14730606T patent/ES2705074T3/es active Active
- 2014-05-30 MA MA38688A patent/MA38688B1/fr unknown
- 2014-05-30 DK DK14730606.2T patent/DK3003383T3/da active
- 2014-05-30 LT LTEP14730606.2T patent/LT3003383T/lt unknown
- 2014-05-30 TR TR2018/21157T patent/TR201821157T4/tr unknown
- 2014-05-30 MX MX2015016497A patent/MX364680B/es active IP Right Grant
- 2014-05-30 PT PT14730606T patent/PT3003383T/pt unknown
- 2014-05-30 WO PCT/PT2014/000036 patent/WO2014193255A1/en active Application Filing
- 2014-05-30 HU HUE14730606A patent/HUE040666T2/hu unknown
- 2014-05-30 US US14/894,097 patent/US20160106766A1/en not_active Abandoned
-
2015
- 2015-11-27 CL CL2015003468A patent/CL2015003468A1/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| TR201821157T4 (tr) | 2019-02-21 |
| PT3003383T (pt) | 2019-01-16 |
| PT106978A (pt) | 2014-12-02 |
| WO2014193255A1 (en) | 2014-12-04 |
| EP3003383A1 (en) | 2016-04-13 |
| PL3003383T3 (pl) | 2019-04-30 |
| MA38688A1 (fr) | 2017-07-31 |
| MA38688B1 (fr) | 2018-08-31 |
| EP3003383B1 (en) | 2018-10-03 |
| MX364680B (es) | 2019-05-03 |
| US20160106766A1 (en) | 2016-04-21 |
| LT3003383T (lt) | 2019-03-12 |
| HUE040666T2 (hu) | 2019-08-28 |
| SI3003383T1 (sl) | 2019-03-29 |
| MX2015016497A (es) | 2016-09-08 |
| RS58133B1 (sr) | 2019-02-28 |
| ES2705074T3 (es) | 2019-03-21 |
| CL2015003468A1 (es) | 2016-07-22 |
| BR112015029897A2 (pt) | 2017-07-25 |
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