PT1888077E - Composição farmacêutica contendo gestagénios e/ou estrogénios e 5-metil-(6s)-tetra-hidrofolato¿ - Google Patents
Composição farmacêutica contendo gestagénios e/ou estrogénios e 5-metil-(6s)-tetra-hidrofolato¿ Download PDFInfo
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- PT1888077E PT1888077E PT06753787T PT06753787T PT1888077E PT 1888077 E PT1888077 E PT 1888077E PT 06753787 T PT06753787 T PT 06753787T PT 06753787 T PT06753787 T PT 06753787T PT 1888077 E PT1888077 E PT 1888077E
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- PT
- Portugal
- Prior art keywords
- methyl
- dosage units
- tetrahydrofolate
- medicament according
- medicament
- Prior art date
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- ZNOVTXRBGFNYRX-STQMWFEESA-N (6S)-5-methyltetrahydrofolic acid Chemical compound C([C@@H]1N(C=2C(=O)N=C(N)NC=2NC1)C)NC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 ZNOVTXRBGFNYRX-STQMWFEESA-N 0.000 title claims description 94
- 229940011871 estrogen Drugs 0.000 title claims description 17
- 239000000262 estrogen Substances 0.000 title claims description 17
- 239000000583 progesterone congener Substances 0.000 title claims description 16
- 239000008194 pharmaceutical composition Substances 0.000 title description 18
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 claims description 87
- 235000019152 folic acid Nutrition 0.000 claims description 66
- 239000011724 folic acid Substances 0.000 claims description 62
- 239000003814 drug Substances 0.000 claims description 49
- BFPYWIDHMRZLRN-UHFFFAOYSA-N 17alpha-ethynyl estradiol Natural products OC1=CC=C2C3CCC(C)(C(CC4)(O)C#C)C4C3CCC2=C1 BFPYWIDHMRZLRN-UHFFFAOYSA-N 0.000 claims description 37
- BFPYWIDHMRZLRN-SLHNCBLASA-N Ethinyl estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 BFPYWIDHMRZLRN-SLHNCBLASA-N 0.000 claims description 37
- 229960002568 ethinylestradiol Drugs 0.000 claims description 37
- 229940014144 folate Drugs 0.000 claims description 37
- 238000000034 method Methods 0.000 claims description 33
- 239000000203 mixture Substances 0.000 claims description 32
- 230000008569 process Effects 0.000 claims description 24
- METQSPRSQINEEU-UHFFFAOYSA-N dihydrospirorenone Natural products CC12CCC(C3(CCC(=O)C=C3C3CC33)C)C3C1C1CC1C21CCC(=O)O1 METQSPRSQINEEU-UHFFFAOYSA-N 0.000 claims description 23
- 229960004845 drospirenone Drugs 0.000 claims description 23
- METQSPRSQINEEU-HXCATZOESA-N drospirenone Chemical compound C([C@]12[C@H]3C[C@H]3[C@H]3[C@H]4[C@@H]([C@]5(CCC(=O)C=C5[C@@H]5C[C@@H]54)C)CC[C@@]31C)CC(=O)O2 METQSPRSQINEEU-HXCATZOESA-N 0.000 claims description 23
- -1 quinestranol Chemical compound 0.000 claims description 21
- 239000000126 substance Substances 0.000 claims description 18
- WWYNJERNGUHSAO-XUDSTZEESA-N (+)-Norgestrel Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 WWYNJERNGUHSAO-XUDSTZEESA-N 0.000 claims description 17
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- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 claims description 14
- 108010030837 Methylenetetrahydrofolate Reductase (NADPH2) Proteins 0.000 claims description 13
- 102000005954 Methylenetetrahydrofolate Reductase (NADPH2) Human genes 0.000 claims description 13
- JMNIIIQOMSQWJN-ZEXVLMPOSA-L calcium;(2s)-2-[[4-[[(6s)-2-amino-5-methyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methylamino]benzoyl]amino]-5-hydroxy-5-oxopentanoate Chemical compound [Ca+2].C([C@@H]1N(C=2C(=O)NC(N)=NC=2NC1)C)NC1=CC=C(C(=O)N[C@@H](CCC([O-])=O)C(O)=O)C=C1.C([C@@H]1N(C=2C(=O)NC(N)=NC=2NC1)C)NC1=CC=C(C(=O)N[C@@H](CCC([O-])=O)C(O)=O)C=C1 JMNIIIQOMSQWJN-ZEXVLMPOSA-L 0.000 claims description 12
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- 206010016880 Folate deficiency Diseases 0.000 claims description 10
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 claims description 10
- 230000007774 longterm Effects 0.000 claims description 9
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- VIKNJXKGJWUCNN-XGXHKTLJSA-N norethisterone Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 VIKNJXKGJWUCNN-XGXHKTLJSA-N 0.000 claims description 9
- 239000005460 tetrahydrofolate Substances 0.000 claims description 9
- AUNGANRZJHBGPY-UHFFFAOYSA-N D-Lyxoflavin Natural products OCC(O)C(O)C(O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-UHFFFAOYSA-N 0.000 claims description 8
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- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 claims description 7
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- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 claims description 6
- 108010075604 5-Methyltetrahydrofolate-Homocysteine S-Methyltransferase Proteins 0.000 claims description 6
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- GCKFUYQCUCGESZ-BPIQYHPVSA-N etonogestrel Chemical compound O=C1CC[C@@H]2[C@H]3C(=C)C[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 GCKFUYQCUCGESZ-BPIQYHPVSA-N 0.000 claims description 6
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- KIQQMECNKUGGKA-NMYWJIRASA-N norgestimate Chemical compound O/N=C/1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(OC(C)=O)C#C)[C@@H]4[C@@H]3CCC2=C\1 KIQQMECNKUGGKA-NMYWJIRASA-N 0.000 claims description 5
- DNXHEGUUPJUMQT-UHFFFAOYSA-N (+)-estrone Natural products OC1=CC=C2C3CCC(C)(C(CC4)=O)C4C3CCC2=C1 DNXHEGUUPJUMQT-UHFFFAOYSA-N 0.000 claims description 4
- PROQIPRRNZUXQM-UHFFFAOYSA-N (16alpha,17betaOH)-Estra-1,3,5(10)-triene-3,16,17-triol Natural products OC1=CC=C2C3CCC(C)(C(C(O)C4)O)C4C3CCC2=C1 PROQIPRRNZUXQM-UHFFFAOYSA-N 0.000 claims description 4
- ATXHVCQZZJYMCF-XUDSTZEESA-N Allylestrenol Chemical compound C1CC[C@@H]2[C@H]3CC[C@](C)([C@](CC4)(O)CC=C)[C@@H]4[C@@H]3CCC2=C1 ATXHVCQZZJYMCF-XUDSTZEESA-N 0.000 claims description 4
- 241000283073 Equus caballus Species 0.000 claims description 4
- DNXHEGUUPJUMQT-CBZIJGRNSA-N Estrone Chemical compound OC1=CC=C2[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CCC2=C1 DNXHEGUUPJUMQT-CBZIJGRNSA-N 0.000 claims description 4
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- AZFLJNIPTRTECV-FUMNGEBKSA-N dienogest Chemical compound C1CC(=O)C=C2CC[C@@H]([C@H]3[C@@](C)([C@](CC3)(O)CC#N)CC3)C3=C21 AZFLJNIPTRTECV-FUMNGEBKSA-N 0.000 claims description 4
- 229940007690 drospirenone and ethinylestradiol Drugs 0.000 claims description 4
- 229960004913 dydrogesterone Drugs 0.000 claims description 4
- JGMOKGBVKVMRFX-HQZYFCCVSA-N dydrogesterone Chemical compound C1=CC2=CC(=O)CC[C@@]2(C)[C@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 JGMOKGBVKVMRFX-HQZYFCCVSA-N 0.000 claims description 4
- AJIPIJNNOJSSQC-NYLIRDPKSA-N estetrol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H]([C@H](O)[C@@H]4O)O)[C@@H]4[C@@H]3CCC2=C1 AJIPIJNNOJSSQC-NYLIRDPKSA-N 0.000 claims description 4
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- GRXPVLPQNMUNNX-MHJRRCNVSA-N estrane Chemical compound C1CC2CCCC[C@@H]2[C@@H]2[C@@H]1[C@@H]1CCC[C@@]1(C)CC2 GRXPVLPQNMUNNX-MHJRRCNVSA-N 0.000 claims description 4
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- PROQIPRRNZUXQM-ZXXIGWHRSA-N estriol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H]([C@H](O)C4)O)[C@@H]4[C@@H]3CCC2=C1 PROQIPRRNZUXQM-ZXXIGWHRSA-N 0.000 claims description 4
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- SIGSPDASOTUPFS-XUDSTZEESA-N gestodene Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](C=C4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 SIGSPDASOTUPFS-XUDSTZEESA-N 0.000 claims description 4
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- FRQMUZJSZHZSGN-HBNHAYAOSA-N medroxyprogesterone Chemical compound C([C@@]12C)CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2CC[C@]2(C)[C@@](O)(C(C)=O)CC[C@H]21 FRQMUZJSZHZSGN-HBNHAYAOSA-N 0.000 claims description 4
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- ISHXLNHNDMZNMC-VTKCIJPMSA-N (3e,8r,9s,10r,13s,14s,17r)-13-ethyl-17-ethynyl-3-hydroxyimino-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-ol Chemical compound O/N=C/1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C\1 ISHXLNHNDMZNMC-VTKCIJPMSA-N 0.000 claims description 3
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- ZMLDTNLDYRJTAZ-GDLCRWSOSA-N 3b-Hydroxydesogestrel Chemical compound O[C@H]1CC[C@@H]2[C@H]3C(=C)C[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 ZMLDTNLDYRJTAZ-GDLCRWSOSA-N 0.000 claims description 3
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- JKQQZJHNUVDHKP-FQJIPJFPSA-N Flurogestone acetate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1CC[C@@](C(C)=O)(OC(=O)C)[C@@]1(C)C[C@@H]2O JKQQZJHNUVDHKP-FQJIPJFPSA-N 0.000 claims description 3
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Landscapes
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| DE102005023301A DE102005023301B4 (de) | 2005-05-13 | 2005-05-13 | Pharmazeutische Zusammensetzung enthaltend Gestagene und/oder Estrogene und 5-Methyl-(6S)-tetrahydrofolat |
| DE102006016285A DE102006016285A1 (de) | 2006-04-03 | 2006-04-03 | Pharmazeutische Zusammensetzung enthaltend Gestagene und/oder Estrogene und 5-Methyl-(6S)-tetrahydrofolat |
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| PT09075120T PT2116249E (pt) | 2005-05-13 | 2006-05-15 | Composição farmacêutica contendo gestagénios e/ou estrogénios e 5-metil-(6s)-tetra-hidrofolato |
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| UY29527A1 (es) | 2005-05-13 | 2006-12-29 | Schering Ag | Composicinn farmaccutica que contienen gestrgenos y/o estrngenos y 5-metil - (6s) - tetrhidrofolato. |
| KR20090029824A (ko) * | 2006-07-06 | 2009-03-23 | 바이엘 쉐링 파마 악티엔게젤샤프트 | 피임용 및 선천성 기형 위험 예방용 제약 제제 |
| US8617597B2 (en) | 2006-07-06 | 2013-12-31 | Bayer Intellectual Property Gmbh | Pharmaceutical composition containing a tetrahydrofolic acid |
| CN101489563A (zh) | 2006-07-06 | 2009-07-22 | 拜耳先灵医药股份有限公司 | 用于避孕和预防先天性畸形风险的药物制剂 |
| EP1891959A1 (de) * | 2006-08-14 | 2008-02-27 | Bayer Schering Pharma Aktiengesellschaft | Pharmazeutische Zusammensetzung zur Kontrazeption und zur Verminderung des Risikos angeborener Fehlbildungen |
| CA2683093A1 (en) * | 2007-04-05 | 2008-10-16 | Bayer Schering Pharma Aktiengesellschaft | New drospirenone/17.beta.-estradiol regimen, pharmaceutical combination product and kit for performing this regimen |
| EA201070715A1 (ru) * | 2007-12-20 | 2011-02-28 | Тева Вимен'С Хелс, Инк. | Режимы дозирования, фармацевтические композиции и упаковки для экстренной контрацепции |
| WO2009112231A2 (en) * | 2008-03-10 | 2009-09-17 | Schuermann Rolf | New drospirenone/17beta-estradil regimen, pharmaceutical combination product and kit for performing this regimen |
| TW200946542A (en) * | 2008-03-10 | 2009-11-16 | Vladimir Hanes | New drospirenone/17β-estradiol regimen, pharmaceutical combination product and kit for performing this regimen |
| AU2011240102B2 (en) | 2010-04-15 | 2015-07-23 | Bayer Intellectual Property Gmbh | Very low-dosed solid oral dosage forms for HRT |
| EP2383279A1 (en) | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
| EP2617422A1 (en) * | 2012-01-20 | 2013-07-24 | Isofol Medical AB | Anti-tumor activity of reduced folates like methylene-tetrahydrofolate, tetrahydrofolate or methyl-tetrahydrofolate |
| EP2781214A1 (en) | 2013-03-22 | 2014-09-24 | Chemo Research, S.L. | Formulation of amorphous calcium L-5-methyltetrahydrofolate (L-5-MTHF-Ca) |
| CN107812195B (zh) * | 2014-09-04 | 2021-04-20 | 连云港金康和信药业有限公司 | (6s)‐5‐甲基‐四氢叶酸钙盐的稳定药物组合物 |
| JP6866561B2 (ja) | 2015-06-18 | 2021-04-28 | エステトラ ソシエテ プリーヴ ア レスポンサビリテ リミテ | エステトロールを含有する口腔内崩壊錠 |
| HRP20200850T1 (hr) | 2015-06-18 | 2020-10-02 | Estetra Sprl | Orodisperzibilna jedinica za doziranje koja sadrži komponentu estetrola |
| EP3106148B1 (en) | 2015-06-18 | 2018-03-14 | Mithra Pharmaceuticals S.A. | Orodispersible dosage unit containing an estetrol component |
| KR102712911B1 (ko) | 2016-08-05 | 2024-10-04 | 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 | 월경통 및 생리통의 관리방법 |
| CN106336444A (zh) * | 2016-08-23 | 2017-01-18 | 国家卫生计生委科学技术研究所 | 一种新晶型炔雌醇 |
| JOP20200260A1 (ar) | 2018-04-19 | 2019-10-19 | Estetra Sprl | مركبات واستخداماتها للتخفيف من الأعراض المصاحبة لانقطاع الطمث |
| TWI801561B (zh) | 2018-04-19 | 2023-05-11 | 比利時商依思特拉私人有限責任公司 | 化合物及其用於緩解絕經相關症狀的用途 |
| TWI893101B (zh) | 2020-04-16 | 2025-08-11 | 比利時商埃斯特拉有限責任公司 | 具有降低之副作用之避孕組成物 |
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| ZA939565B (en) * | 1993-12-21 | 1994-08-11 | Applied Analytical Ind Inc | Method for preparing low dose pharmaceutical products. |
| US6083528A (en) * | 1995-09-28 | 2000-07-04 | Schering Aktiengesellschaft | Hormone replacement therapy method and hormone dispenser |
| WO1997015191A1 (en) * | 1995-10-27 | 1997-05-01 | Merck & Co., Inc. | Wet granulation formulation of a growth hormone secretagogue |
| US5997915A (en) | 1996-01-31 | 1999-12-07 | South Alabama Medical Science Foundation | Compositions for human and animal consumption containing reduced folates and methods for making and using same |
| CH693255A5 (de) | 1997-06-13 | 2003-05-15 | Eprova Ag | Verwendung von Tetrahydrofolaten in der natürlichenstereoisomeren Form zur Herstellung einer pharmazeutischenZubereitung geeignet zur Beeinflussung des Homocystein-Spiegels. |
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| US6326392B1 (en) | 1997-11-06 | 2001-12-04 | American Home Products Corporation | Anti-estrogen plus progestin containing oral contraceptives |
| EP2002839A1 (en) | 1998-04-17 | 2008-12-17 | Ortho McNeil Pharmaceutical, Inc. | Folic acid-containing pharmaceutical compositions, and related methods and delivery systems |
| WO2000023089A1 (en) * | 1998-10-19 | 2000-04-27 | Merck Patent Gmbh | Natural formulation for the treatment and prevention of depression, containing st john's wort and derivatives of dihydro- and tetrahydrofolic acid |
| US7014865B1 (en) | 1998-10-19 | 2006-03-21 | Merck Patent Gmbh | Natural formulation for the treatment and prevention of depression, containing St. John's Wort and derivatives of dihydro- and tetrahydrofolic acid |
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| UY29527A1 (es) | 2005-05-13 | 2006-12-29 | Schering Ag | Composicinn farmaccutica que contienen gestrgenos y/o estrngenos y 5-metil - (6s) - tetrhidrofolato. |
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2006
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- 2006-05-12 SV SV2006002527A patent/SV2008002527A/es active IP Right Grant
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- 2006-05-12 AR ARP060101915A patent/AR054123A1/es not_active Application Discontinuation
- 2006-05-15 EA EA200702349A patent/EA014664B1/ru active Protection Beyond IP Right Term
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- 2006-05-15 CA CA2608639A patent/CA2608639C/en not_active Expired - Fee Related
- 2006-05-15 PL PL09075120T patent/PL2116249T3/pl unknown
- 2006-05-15 SI SI200630360T patent/SI1888077T1/sl unknown
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- 2006-05-15 KR KR1020147010192A patent/KR101598735B1/ko active Active
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- 2006-05-15 EP EP09075120.7A patent/EP2116249B2/de active Active
- 2006-05-15 CN CN2010101564516A patent/CN101954083A/zh active Pending
- 2006-05-15 WO PCT/EP2006/004858 patent/WO2006120035A2/de not_active Ceased
- 2006-05-15 EA EA200901393A patent/EA028530B1/ru not_active IP Right Cessation
- 2006-05-15 JP JP2008510518A patent/JP2008540482A/ja not_active Withdrawn
- 2006-05-15 AT AT06753787T patent/ATE429917T1/de active
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- 2006-05-15 PL PL06753787T patent/PL1888077T3/pl unknown
- 2006-05-15 AU AU2006245921A patent/AU2006245921A1/en not_active Abandoned
- 2006-05-15 DE DE502006003617T patent/DE502006003617D1/de active Active
- 2006-05-15 ES ES06753787T patent/ES2325600T3/es active Active
- 2006-05-15 PT PT09075120T patent/PT2116249E/pt unknown
- 2006-05-15 EP EP10185658A patent/EP2298307A1/de not_active Withdrawn
- 2006-05-15 KR KR1020077029090A patent/KR20080028369A/ko not_active Ceased
- 2006-05-15 DK DK09075120.7T patent/DK2116249T3/da active
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- 2006-05-15 CN CN2006800164109A patent/CN101198332B/zh active Active
- 2006-05-15 ES ES09075120T patent/ES2387525T5/es active Active
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2007
- 2007-11-12 TN TNP2007000418A patent/TNSN07418A1/en unknown
- 2007-11-12 US US11/938,688 patent/US20080160004A1/en not_active Abandoned
- 2007-11-13 MA MA30367A patent/MA29448B1/fr unknown
- 2007-11-13 IL IL187340A patent/IL187340A/en active IP Right Grant
- 2007-11-16 CR CR9531A patent/CR9531A/es not_active Application Discontinuation
- 2007-12-11 EC EC2007008001A patent/ECSP078001A/es unknown
- 2007-12-12 ZA ZA2007/10811A patent/ZA200710811B/en unknown
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2009
- 2009-07-28 CY CY20091100804T patent/CY1109261T1/el unknown
- 2009-12-14 ZA ZA2009/08894A patent/ZA200908894B/en unknown
- 2009-12-18 CL CL2009002187A patent/CL2009002187A1/es unknown
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2010
- 2010-09-21 CL CL2010000989A patent/CL2010000989A1/es unknown
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2012
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2013
- 2013-02-18 JP JP2013029277A patent/JP5883810B2/ja active Active
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2015
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