PL2058296T3 - Nowa postać krystaliczna VI agomelatyny, sposób jej wytwarzania i kompozycje farmaceutyczne ją zawierające - Google Patents
Nowa postać krystaliczna VI agomelatyny, sposób jej wytwarzania i kompozycje farmaceutyczne ją zawierająceInfo
- Publication number
- PL2058296T3 PL2058296T3 PL08291042T PL08291042T PL2058296T3 PL 2058296 T3 PL2058296 T3 PL 2058296T3 PL 08291042 T PL08291042 T PL 08291042T PL 08291042 T PL08291042 T PL 08291042T PL 2058296 T3 PL2058296 T3 PL 2058296T3
- Authority
- PL
- Poland
- Prior art keywords
- agomelatine
- preparation
- pharmaceutical compositions
- crystalline form
- new crystalline
- Prior art date
Links
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C233/00—Carboxylic acid amides
- C07C233/01—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
- C07C233/02—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having nitrogen atoms of carboxamide groups bound to hydrogen atoms or to carbon atoms of unsubstituted hydrocarbon radicals
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C233/00—Carboxylic acid amides
- C07C233/01—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
- C07C233/16—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms
- C07C233/17—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by an acyclic carbon atom
- C07C233/18—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by an acyclic carbon atom having the carbon atom of the carboxamide group bound to a hydrogen atom or to a carbon atom of an acyclic saturated carbon skeleton
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
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- 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
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- 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
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- 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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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- A—HUMAN NECESSITIES
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- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
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- A61P15/18—Feminine contraceptives
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- A—HUMAN NECESSITIES
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- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
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- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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- A61P25/20—Hypnotics; Sedatives
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- A—HUMAN NECESSITIES
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
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- A—HUMAN NECESSITIES
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- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
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- A61P3/04—Anorexiants; Antiobesity agents
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C231/00—Preparation of carboxylic acid amides
- C07C231/08—Preparation of carboxylic acid amides from amides by reaction at nitrogen atoms of carboxamide groups
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Diabetes (AREA)
- Pain & Pain Management (AREA)
- Obesity (AREA)
- Gynecology & Obstetrics (AREA)
- Psychiatry (AREA)
- Immunology (AREA)
- Hematology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Anesthesiology (AREA)
- Cardiology (AREA)
- Child & Adolescent Psychology (AREA)
- Emergency Medicine (AREA)
- Pregnancy & Childbirth (AREA)
- Nutrition Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Hospice & Palliative Care (AREA)
- Psychology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0707861A FR2923482B1 (fr) | 2007-11-09 | 2007-11-09 | Nouvelle forme cristalline vi de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL2058296T3 true PL2058296T3 (pl) | 2017-03-31 |
Family
ID=39535664
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL08291042T PL2058296T3 (pl) | 2007-11-09 | 2008-11-07 | Nowa postać krystaliczna VI agomelatyny, sposób jej wytwarzania i kompozycje farmaceutyczne ją zawierające |
Country Status (45)
Families Citing this family (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2934856B1 (fr) * | 2008-08-05 | 2010-08-13 | Servier Lab | Nouveau procede d'obtention de la forme cristalline v de l'agomelatine |
| CN101585779B (zh) * | 2009-03-10 | 2014-04-02 | 上海医药工业研究院 | 阿戈美拉汀的晶型vi及其制备方法和应用 |
| WO2011006387A1 (zh) * | 2009-07-11 | 2011-01-20 | 浙江华海药业股份有限公司 | 阿戈美拉汀的制备方法、阿戈美拉汀晶形及其制备方法 |
| CN101955440B (zh) * | 2009-07-17 | 2014-04-09 | 江苏万特制药有限公司 | 一种阿戈美拉汀新晶型及其制备方法 |
| CN102001959B (zh) * | 2009-09-01 | 2014-07-02 | 北京本草天源药物研究院 | 一种药物晶体及其制备方法和用途 |
| EP2319827A1 (en) | 2009-11-09 | 2011-05-11 | Ratiopharm GmbH | Process for the production of polymorph form I of agomelatine |
| CN101781226B (zh) * | 2009-12-23 | 2012-03-28 | 天津泰普药品科技发展有限公司 | 阿戈美拉汀及其药物组合物 |
| EP2558440B1 (en) | 2010-04-15 | 2016-11-16 | ratiopharm GmbH | Process for the production of polymorph form i of agomelatine |
| WO2012046253A2 (en) * | 2010-10-08 | 2012-04-12 | Msn Laboratories Limited | Process for the preparation of n-[2- (7-methoxy-l-naphthyl) ethyl] acetamide and its novel crystalline forms |
| CZ303787B6 (cs) | 2011-01-21 | 2013-05-02 | Zentiva, K.S. | Metastabilní krystalové formy agomelatinu a jejich farmaceutické kompozice |
| CN102690209A (zh) * | 2011-03-23 | 2012-09-26 | 上海医药工业研究院 | 阿戈美拉汀的混晶(形式-ⅷ)、其制备方法、应用和包含其的药物组合物 |
| WO2012130837A1 (en) | 2011-03-28 | 2012-10-04 | Ratiopharm Gmbh | Solid agomelatine in non-crystalline form |
| CN102206864B (zh) * | 2011-04-13 | 2012-10-03 | 吉林省博大伟业制药有限公司 | 阿戈美拉汀的ⅵ晶型单晶及混合晶型和制备方法 |
| PH12012000132A1 (en) * | 2011-06-09 | 2014-10-20 | Servier Lab | New co-crystals of agomelatine, a process for their preparation and pharmaceutical compositions containing them |
| WO2013082302A1 (en) | 2011-11-30 | 2013-06-06 | Ratiopharm Gmbh | Agomelatine-urea complex and crystalline forms thereof |
| CZ2012108A3 (en) | 2012-02-15 | 2013-02-27 | Zentiva Ks | A method for the manufacture of a polymorphously stable pharmaceutical composition containing agomelatine |
| EP2872129B1 (en) | 2012-07-16 | 2017-03-08 | ratiopharm GmbH | Complex of agomelatine and cyclodextrin |
| CN102988315B (zh) * | 2012-09-28 | 2017-11-17 | 浙江华海药业股份有限公司 | 阿戈美拉汀固体制剂的制备方法 |
| WO2014072998A1 (en) | 2012-11-07 | 2014-05-15 | Cadila Healthcare Limited | An improved process for preparation of agomelatine |
| EP2934502A1 (en) | 2012-12-21 | 2015-10-28 | Laboratorios Lesvi S.L. | Process for prepararing n-(2-(7-methoxy-1-naphthalenyl)ethyl) acetamide and solid forms thereof |
| EP2810647A1 (en) | 2013-06-06 | 2014-12-10 | Zentiva, a.s. | Pharmaceutical formulations comprising agomelatine in the form of agomelatine co-crystal with an organic acid |
| HUE036989T2 (hu) | 2013-06-06 | 2018-08-28 | Zentiva Ks | Agomelatin készítmény, amely agomelatint ko-kristály formájában tartalmaz |
| CZ2013621A3 (cs) | 2013-08-13 | 2015-02-25 | Zentiva, K.S. | Termodynamicky stabilní tuhý roztok agomelatinu pro použití ve farmaceutické formulaci |
| WO2015124496A1 (en) | 2014-02-19 | 2015-08-27 | Synthon B.V. | Pharmaceutical composition comprising amorphous agomelatine |
| EP3075724B1 (en) | 2015-03-31 | 2023-07-12 | F.I.S.- Fabbrica Italiana Sintetici S.p.A. | Solid form of agomelatine |
| EP3466923A1 (en) | 2017-10-09 | 2019-04-10 | KRKA, d.d., Novo mesto | Process for the preparation of agomelatine in crystalline form |
| EP3466413A1 (en) | 2017-10-09 | 2019-04-10 | KRKA, d.d., Novo mesto | Pharmaceutical composition containing agomelatine and process for the preparation thereof |
| CN114028335A (zh) * | 2021-12-24 | 2022-02-11 | 山东京卫制药有限公司 | 一种阿戈美拉汀溶液鼻喷剂及其应用 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1146164B (it) | 1980-07-16 | 1986-11-12 | Selenia Ind Elettroniche | Dispositivo di filtraggio doppler adattivo alla situazione di clutter ed ecm esterna per impianti radar |
| FR2658818B1 (fr) * | 1990-02-27 | 1993-12-31 | Adir Cie | Nouveaux derives a structure naphtalenique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent. |
| CZ2003529A3 (cs) * | 2000-07-27 | 2003-09-17 | Teva Pharmaceutical Industries Ltd. | Krystalický a čistý modafinil a postup jeho přípravy |
| US6992219B2 (en) * | 2002-08-09 | 2006-01-31 | Cephalon France | Modafinil polymorphic forms |
| FR2866335B1 (fr) * | 2004-02-13 | 2006-05-26 | Servier Lab | Nouveau procede de synthese de l'agomelatine |
| US7645905B2 (en) * | 2005-08-03 | 2010-01-12 | Les Laboratoires Servier | Crystalline form IV of agomelatine, a process for its preparation and pharmaceutical compositions containing it |
| FR2889522B1 (fr) * | 2005-08-03 | 2007-12-28 | Servier Lab | Nouvelle forme cristalline iv de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent |
| US7635721B2 (en) * | 2005-08-03 | 2009-12-22 | Les Laboratoires Servier | Crystalline form III of agomelatine, a process for its preparation and pharmaceutical compositions containing it |
| US7358395B2 (en) * | 2005-08-03 | 2008-04-15 | Les Laboratories Servier | Crystalline form V of agomelatine, a process for its preparation and pharmaceutical compositions containing it |
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2007
- 2007-11-09 FR FR0707861A patent/FR2923482B1/fr active Active
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2008
- 2008-10-22 MY MYPI20084216A patent/MY148319A/en unknown
- 2008-10-22 SG SG200807861-0A patent/SG152991A1/en unknown
- 2008-10-23 UY UY31419A patent/UY31419A1/es not_active Application Discontinuation
- 2008-10-24 CN CN2008101749182A patent/CN101429134B/zh not_active Expired - Fee Related
- 2008-10-24 CU CU20080200A patent/CU20080200A7/es unknown
- 2008-10-27 PE PE2008001833A patent/PE20090912A1/es not_active Application Discontinuation
- 2008-10-27 IL IL194931A patent/IL194931A/en active IP Right Grant
- 2008-10-27 MX MX2008013782A patent/MX2008013782A/es active IP Right Grant
- 2008-10-28 CR CR10406A patent/CR10406A/es unknown
- 2008-10-30 TW TW097141871A patent/TWI356051B/zh not_active IP Right Cessation
- 2008-10-31 CO CO08116976A patent/CO6120149A1/es not_active Application Discontinuation
- 2008-10-31 ZA ZA200809358A patent/ZA200809358B/en unknown
- 2008-11-04 SV SV2008003088A patent/SV2008003088A/es active IP Right Grant
- 2008-11-04 EC EC2008008859A patent/ECSP088859A/es unknown
- 2008-11-04 UA UAA200812882A patent/UA97478C2/ru unknown
- 2008-11-04 MA MA31357A patent/MA30464B1/fr unknown
- 2008-11-04 GE GEAP200810961A patent/GEP20125579B/en unknown
- 2008-11-05 CA CA2643622A patent/CA2643622C/fr not_active Expired - Fee Related
- 2008-11-06 JO JOP/2008/0509A patent/JO3178B1/ar active
- 2008-11-06 EA EA200802119A patent/EA015402B1/ru unknown
- 2008-11-06 NI NI200800294A patent/NI200800294A/es unknown
- 2008-11-06 US US12/291,143 patent/US8067639B2/en not_active Expired - Fee Related
- 2008-11-06 AU AU2008243132A patent/AU2008243132B2/en not_active Ceased
- 2008-11-07 ME MEP-2017-1A patent/ME02701B/me unknown
- 2008-11-07 HU HUE08291042A patent/HUE030048T2/hu unknown
- 2008-11-07 AR ARP080104875A patent/AR071253A1/es unknown
- 2008-11-07 PT PT82910423T patent/PT2058296T/pt unknown
- 2008-11-07 WO PCT/FR2008/001576 patent/WO2009095555A1/fr active Application Filing
- 2008-11-07 SI SI200831742A patent/SI2058296T1/sl unknown
- 2008-11-07 CL CL2008003316A patent/CL2008003316A1/es unknown
- 2008-11-07 LT LTEP08291042.3T patent/LT2058296T/lt unknown
- 2008-11-07 KR KR1020080110522A patent/KR20090048364A/ko not_active Application Discontinuation
- 2008-11-07 NZ NZ572636A patent/NZ572636A/en not_active IP Right Cessation
- 2008-11-07 JP JP2008286059A patent/JP2009137943A/ja active Pending
- 2008-11-07 EP EP08291042.3A patent/EP2058296B1/fr active Active
- 2008-11-07 PL PL08291042T patent/PL2058296T3/pl unknown
- 2008-11-07 ES ES08291042.3T patent/ES2608961T3/es active Active
- 2008-11-07 DK DK08291042.3T patent/DK2058296T3/en active
- 2008-11-07 RS RS20161012A patent/RS55316B1/sr unknown
- 2008-11-08 SA SA08290715A patent/SA08290715B1/ar unknown
- 2008-11-10 BR BRPI0804994-7A patent/BRPI0804994A2/pt not_active Application Discontinuation
-
2009
- 2009-10-21 HK HK09109759.3A patent/HK1131777A1/xx not_active IP Right Cessation
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2016
- 2016-11-03 CY CY20161101117T patent/CY1118196T1/el unknown
- 2016-12-08 HR HRP20161672TT patent/HRP20161672T1/hr unknown
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