CA2671968A1 - Abeta antibody parenteral formulation - Google Patents
Abeta antibody parenteral formulation Download PDFInfo
- Publication number
- CA2671968A1 CA2671968A1 CA002671968A CA2671968A CA2671968A1 CA 2671968 A1 CA2671968 A1 CA 2671968A1 CA 002671968 A CA002671968 A CA 002671968A CA 2671968 A CA2671968 A CA 2671968A CA 2671968 A1 CA2671968 A1 CA 2671968A1
- Authority
- CA
- Canada
- Prior art keywords
- formulation
- histidine
- abeta antibody
- formulation according
- tween
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
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- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Genetics & Genomics (AREA)
- General Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Dermatology (AREA)
- Neurology (AREA)
- Biophysics (AREA)
- Hospice & Palliative Care (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Psychiatry (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP06025590.8 | 2006-12-11 | ||
| EP06025590 | 2006-12-11 | ||
| PCT/EP2007/010825 WO2008071394A1 (en) | 2006-12-11 | 2007-12-11 | Abeta antibody parenteral formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2671968A1 true CA2671968A1 (en) | 2008-06-19 |
Family
ID=39190366
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002671968A Abandoned CA2671968A1 (en) | 2006-12-11 | 2007-12-11 | Abeta antibody parenteral formulation |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US20110070225A1 (enExample) |
| EP (1) | EP2094729A1 (enExample) |
| JP (1) | JP2010512356A (enExample) |
| KR (1) | KR20090104017A (enExample) |
| CN (1) | CN101553504A (enExample) |
| AR (1) | AR064220A1 (enExample) |
| AU (1) | AU2007331712A1 (enExample) |
| BR (1) | BRPI0721097A2 (enExample) |
| CA (1) | CA2671968A1 (enExample) |
| CL (1) | CL2007003583A1 (enExample) |
| CR (1) | CR10823A (enExample) |
| EC (1) | ECSP099403A (enExample) |
| IL (1) | IL198963A0 (enExample) |
| MA (1) | MA30975B1 (enExample) |
| MX (1) | MX2009006199A (enExample) |
| NO (1) | NO20092586L (enExample) |
| PE (1) | PE20081477A1 (enExample) |
| RU (1) | RU2009126420A (enExample) |
| TW (1) | TW200831133A (enExample) |
| WO (1) | WO2008071394A1 (enExample) |
| ZA (1) | ZA200904014B (enExample) |
Families Citing this family (72)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20160279239A1 (en) | 2011-05-02 | 2016-09-29 | Immunomedics, Inc. | Subcutaneous administration of anti-cd74 antibody for systemic lupus erythematosus and autoimmune disease |
| DE10303974A1 (de) | 2003-01-31 | 2004-08-05 | Abbott Gmbh & Co. Kg | Amyloid-β(1-42)-Oligomere, Verfahren zu deren Herstellung und deren Verwendung |
| TW200530269A (en) | 2003-12-12 | 2005-09-16 | Chugai Pharmaceutical Co Ltd | Anti-Mpl antibodies |
| US20160355591A1 (en) | 2011-05-02 | 2016-12-08 | Immunomedics, Inc. | Subcutaneous anti-hla-dr monoclonal antibody for treatment of hematologic malignancies |
| EP1870458B1 (en) | 2005-03-31 | 2018-05-09 | Chugai Seiyaku Kabushiki Kaisha | sc(Fv)2 STRUCTURAL ISOMERS |
| CN101262885B (zh) | 2005-06-10 | 2015-04-01 | 中外制药株式会社 | 含有sc(Fv)2的药物组合物 |
| CN117903302A (zh) | 2005-11-30 | 2024-04-19 | Abbvie 公司 | 抗-Aβ球聚体抗体，其相关产品，生产所述抗体的方法，所述抗体的应用以及使用方法 |
| PT1976877E (pt) | 2005-11-30 | 2014-04-29 | Abbvie Inc | Anticorpos monoclonais contra proteína beta-amilóide e suas utilizações |
| AR057233A1 (es) * | 2005-12-12 | 2007-11-21 | Hoffmann La Roche | Glicosilacion en la region variable |
| US8455626B2 (en) | 2006-11-30 | 2013-06-04 | Abbott Laboratories | Aβ conformer selective anti-aβ globulomer monoclonal antibodies |
| US20100311767A1 (en) | 2007-02-27 | 2010-12-09 | Abbott Gmbh & Co. Kg | Method for the treatment of amyloidoses |
| US8613923B2 (en) | 2007-06-12 | 2013-12-24 | Ac Immune S.A. | Monoclonal antibody |
| US8048420B2 (en) | 2007-06-12 | 2011-11-01 | Ac Immune S.A. | Monoclonal antibody |
| ES2445590T3 (es) | 2007-10-05 | 2014-03-04 | Genentech, Inc. | Uso de anticuerpo anti-amiloide beta en enfermedades oculares |
| EA201001467A1 (ru) | 2008-03-14 | 2011-06-30 | Биокон Лимитед | Моноклональное антитело и способ его использования |
| KR20170116193A (ko) * | 2008-06-20 | 2017-10-18 | 노파르티스 아게 | 응집이 감소된 면역글로불린 |
| JP5524967B2 (ja) * | 2008-09-19 | 2014-06-18 | エフ．ホフマン−ラ ロシュ アーゲー | 新規抗体処方物 |
| EP4104821A1 (en) | 2008-10-29 | 2022-12-21 | Ablynx N.V. | Formulations of single domain antigen binding molecules |
| CA2739352C (en) | 2008-10-29 | 2021-07-13 | Wyeth Llc | Methods for purification of single domain antigen binding molecules |
| RU2563823C2 (ru) * | 2008-11-17 | 2015-09-20 | Дженентек, Инк. | Способ и композиция для уменьшения агрегации макромолекул при физиологических условиях |
| EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
| WO2010069858A1 (en) * | 2008-12-19 | 2010-06-24 | F. Hoffmann-La Roche Ag | Pharmaceutical composition |
| WO2010100179A2 (en) * | 2009-03-05 | 2010-09-10 | Novartis Ag | Self-forming gel system for sustained drug delivery |
| BR112012012080B1 (pt) * | 2009-11-20 | 2022-11-29 | Biocon Limited | Formulações de histidina-trealose do anticorpo t1h |
| WO2011080209A2 (en) * | 2009-12-29 | 2011-07-07 | F. Hoffmann-La Roche Ag | Novel antibody formulation |
| AR080428A1 (es) | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
| EP3216462A3 (en) | 2010-02-26 | 2017-12-20 | Novo Nordisk A/S | Stable antibody containing compositions |
| DK3345615T3 (da) | 2010-03-01 | 2020-01-20 | Bayer Healthcare Llc | Optimerede monoklonale antistoffer mod inhibitor af vævsfaktoraktiveringsvejen (tfpi) |
| EA201201227A1 (ru) | 2010-03-03 | 2013-04-30 | Бёрингер Ингельхайм Интернациональ Гмбх | Бипаратопные а-бета-связывающие полипептиды |
| CN104744591B (zh) | 2010-04-15 | 2022-09-27 | Abbvie德国有限责任两合公司 | β淀粉样蛋白结合蛋白 |
| KR20130086144A (ko) | 2010-05-28 | 2013-07-31 | 노보 노르디스크 에이/에스 | 항체 및 보존제를 포함하는 안정한 다중-투여 조성물 |
| US9221900B2 (en) | 2010-07-30 | 2015-12-29 | Ac Immune S.A. | Methods for identifying safe and functional humanized antibodies |
| EP3533803B1 (en) | 2010-08-14 | 2021-10-27 | AbbVie Inc. | Anti-amyloid-beta antibodies |
| WO2012028683A1 (en) * | 2010-09-02 | 2012-03-08 | Novartis Ag | Antibody gel system for sustained drug delivery |
| US10040855B2 (en) * | 2011-05-02 | 2018-08-07 | Millennium Pharmaceuticals, Inc. | Formulation for anti-α4β7 antibody |
| UA116189C2 (uk) | 2011-05-02 | 2018-02-26 | Мілленніум Фармасьютікалз, Інк. | КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА |
| WO2012151199A1 (en) | 2011-05-02 | 2012-11-08 | Immunomedics, Inc. | Ultrafiltration concentration of allotype selected antibodies for small-volume administration |
| IN2014CN03555A (enExample) * | 2011-10-25 | 2015-07-03 | Onclave Therapeutics Ltd | |
| SI2822587T1 (sl) * | 2012-03-08 | 2016-04-29 | F. Hoffmann-La Roche Ag | Farmacevtska oblika abeta protitelesa |
| JP6265970B2 (ja) * | 2012-03-26 | 2018-01-24 | サノフイ | 安定なＩｇＧ４に基づく結合剤の製剤 |
| US9592289B2 (en) | 2012-03-26 | 2017-03-14 | Sanofi | Stable IgG4 based binding agent formulations |
| US20130281355A1 (en) | 2012-04-24 | 2013-10-24 | Genentech, Inc. | Cell culture compositions and methods for polypeptide production |
| US9592297B2 (en) * | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| US8883979B2 (en) * | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| CN105025925A (zh) * | 2013-03-15 | 2015-11-04 | 拜尔健康护理有限责任公司 | 抗-催乳素受体抗体制剂 |
| HK1225298A1 (zh) | 2013-07-23 | 2017-09-08 | Biocon Limited | Cd6结合配对体的使用和以其为基础的方法 |
| MD20170055A2 (ro) | 2014-10-24 | 2017-09-30 | Merck Sharp & Dohme Corp | Co-agonişti ai receptorilor glucagonului şi GLP-1 |
| JP6781508B2 (ja) * | 2014-11-18 | 2020-11-04 | 塩野義製薬株式会社 | 安定化されたペプチド組成物 |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| CN104946616A (zh) * | 2015-05-12 | 2015-09-30 | 骏实生物科技(上海)有限公司 | 一种用于体外诊断试剂的通用固体稳定剂及其使用方法 |
| AR104847A1 (es) * | 2015-06-17 | 2017-08-16 | Lilly Co Eli | Formulación de anticuerpo anti-cgrp |
| AU2016282334B2 (en) | 2015-06-24 | 2022-07-21 | F. Hoffmann-La Roche Ag | Anti-transferrin receptor antibodies with tailored affinity |
| KR102669174B1 (ko) * | 2015-08-19 | 2024-06-10 | 아스트라제네카 아베 | 안정한 항-ｉｆｎａｒ1 제형 |
| KR20180037056A (ko) * | 2015-09-22 | 2018-04-10 | 화이자 인코포레이티드 | 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형 |
| AR106189A1 (es) | 2015-10-02 | 2017-12-20 | Hoffmann La Roche | ANTICUERPOS BIESPECÍFICOS CONTRA EL A-b HUMANO Y EL RECEPTOR DE TRANSFERRINA HUMANO Y MÉTODOS DE USO |
| PE20231655A1 (es) | 2015-10-02 | 2023-10-17 | Hoffmann La Roche | Anticuerpos biespecificos contra el cd20 humano y el receptor de transferrina humano y metodos de uso |
| CN106620691B (zh) * | 2015-11-04 | 2020-08-21 | 信达生物制药(苏州)有限公司 | 一种重组全人源抗ctla-4单克隆抗体制剂及其应用 |
| AU2016380988B2 (en) | 2015-12-30 | 2022-07-21 | Genentech, Inc. | Formulations with reduced degradation of polysorbate |
| CN106199007B (zh) * | 2016-08-03 | 2017-04-05 | 烟台普罗吉生物科技发展有限公司 | 蛋白保护剂 |
| KR102514528B1 (ko) | 2016-10-21 | 2023-03-27 | 바이오콘 리미티드 | 루푸스 치료를 위한 단일클론항체 및 이의 치료방법 |
| CN106913869B (zh) * | 2017-03-17 | 2020-07-28 | 信达生物制药(苏州)有限公司 | 一种抗ctla-4单克隆抗体制剂及其应用 |
| EP3606964A4 (en) | 2017-04-03 | 2020-12-09 | Immunomedics, Inc. | SUBCUTANE ADMINISTRATION OF ANTIBODY DRUG CONJUGATES FOR CANCER THERAPY |
| EP4233901A3 (en) * | 2017-08-22 | 2023-09-06 | Biogen MA Inc. | Pharmaceutical compositions containing anti-beta amyloid antibodies |
| CN108373494A (zh) * | 2018-02-27 | 2018-08-07 | 武汉伊艾博科技有限公司 | 一种防止重组蛋白质降解的保护技术 |
| JP7266108B2 (ja) | 2019-02-18 | 2023-04-27 | イーライ リリー アンド カンパニー | 治療用抗体製剤 |
| CN112618482A (zh) * | 2019-09-24 | 2021-04-09 | 江苏恒瑞医药股份有限公司 | 新型蛋白制剂 |
| CN112741804A (zh) * | 2019-10-31 | 2021-05-04 | 上海君实生物医药科技股份有限公司 | 含有抗pd-l1抗体的稳定制剂 |
| CN113116812A (zh) * | 2019-12-30 | 2021-07-16 | 百奥泰生物制药股份有限公司 | 含抗Trop2抗体-药物偶联物的制剂及其制备方法和应用 |
| WO2022072255A1 (en) * | 2020-09-30 | 2022-04-07 | Merck Sharp & Dohme Corp. | Binding proteins and antigen binding fragments thereof that bind abeta |
| US20240417451A1 (en) | 2023-05-31 | 2024-12-19 | Hoffmann-La Roche Inc. | Therapeutic Use of Bispecific Anti-Abeta/TfR Antibodies |
| CN117088974B (zh) * | 2023-08-14 | 2024-02-13 | 武汉健昊生物科技有限公司 | 一种抗体保存液 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6685940B2 (en) * | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| US20030113316A1 (en) * | 2001-07-25 | 2003-06-19 | Kaisheva Elizabet A. | Stable lyophilized pharmaceutical formulation of IgG antibodies |
| AR038568A1 (es) * | 2002-02-20 | 2005-01-19 | Hoffmann La Roche | Anticuerpos anti-a beta y su uso |
| EP2335725B1 (en) * | 2003-04-04 | 2016-10-12 | Genentech, Inc. | High concentration antibody and protein formulations |
| GT200600031A (es) * | 2005-01-28 | 2006-08-29 | Formulacion anticuerpo anti a beta | |
| BRPI0606867A2 (pt) * | 2005-01-28 | 2009-07-21 | Wyeth Corp | formulação lìquida; forma de dosagem unitária farmacêutica; kit; recipiente; método para aumentar a estabilidade de um polipeptìdeo de ligação a antìgeno numa formulação; método para preparar uma forma de dosagem unitária farmacêutica; formulação estável; formulação; e produto terapêutico |
| AR057233A1 (es) * | 2005-12-12 | 2007-11-21 | Hoffmann La Roche | Glicosilacion en la region variable |
| RU2008142359A (ru) * | 2006-03-28 | 2010-05-10 | Ф.Хоффманн-Ля Рош Аг (Ch) | Композиция человеческого моноклонального антитела к igf-1r |
-
2007
- 2007-12-11 TW TW096147285A patent/TW200831133A/zh unknown
- 2007-12-11 BR BRPI0721097-3A patent/BRPI0721097A2/pt not_active IP Right Cessation
- 2007-12-11 RU RU2009126420/10A patent/RU2009126420A/ru not_active Application Discontinuation
- 2007-12-11 AU AU2007331712A patent/AU2007331712A1/en not_active Abandoned
- 2007-12-11 JP JP2009540650A patent/JP2010512356A/ja not_active Withdrawn
- 2007-12-11 CL CL200703583A patent/CL2007003583A1/es unknown
- 2007-12-11 KR KR1020097013954A patent/KR20090104017A/ko not_active Withdrawn
- 2007-12-11 CN CNA2007800455861A patent/CN101553504A/zh active Pending
- 2007-12-11 MX MX2009006199A patent/MX2009006199A/es not_active Application Discontinuation
- 2007-12-11 AR ARP070105523A patent/AR064220A1/es unknown
- 2007-12-11 PE PE2007001764A patent/PE20081477A1/es not_active Application Discontinuation
- 2007-12-11 EP EP07856573A patent/EP2094729A1/en not_active Withdrawn
- 2007-12-11 CA CA002671968A patent/CA2671968A1/en not_active Abandoned
- 2007-12-11 WO PCT/EP2007/010825 patent/WO2008071394A1/en not_active Ceased
- 2007-12-11 US US12/448,190 patent/US20110070225A1/en not_active Abandoned
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2009
- 2009-05-21 CR CR10823A patent/CR10823A/es not_active Application Discontinuation
- 2009-05-26 IL IL198963A patent/IL198963A0/en unknown
- 2009-06-08 MA MA31963A patent/MA30975B1/fr unknown
- 2009-06-09 ZA ZA200904014A patent/ZA200904014B/xx unknown
- 2009-06-11 EC EC2009009403A patent/ECSP099403A/es unknown
- 2009-07-07 NO NO20092586A patent/NO20092586L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CL2007003583A1 (es) | 2008-07-18 |
| IL198963A0 (en) | 2011-08-01 |
| WO2008071394A1 (en) | 2008-06-19 |
| NO20092586L (no) | 2009-07-17 |
| AR064220A1 (es) | 2009-03-18 |
| CR10823A (es) | 2009-08-12 |
| RU2009126420A (ru) | 2011-01-20 |
| MA30975B1 (fr) | 2009-12-01 |
| CN101553504A (zh) | 2009-10-07 |
| EP2094729A1 (en) | 2009-09-02 |
| PE20081477A1 (es) | 2008-10-18 |
| BRPI0721097A2 (pt) | 2014-07-01 |
| US20110070225A1 (en) | 2011-03-24 |
| MX2009006199A (es) | 2009-06-22 |
| ZA200904014B (en) | 2010-04-28 |
| AU2007331712A2 (en) | 2009-07-30 |
| KR20090104017A (ko) | 2009-10-05 |
| AU2007331712A1 (en) | 2008-06-19 |
| JP2010512356A (ja) | 2010-04-22 |
| ECSP099403A (es) | 2009-07-31 |
| TW200831133A (en) | 2008-08-01 |
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| Date | Code | Title | Description |
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| FZDE | Discontinued |
Effective date: 20121211 |