EA015615B1 - Устойчивые к спиртам лекарственные формы - Google Patents

Устойчивые к спиртам лекарственные формы Download PDF

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Publication number
EA015615B1
EA015615B1 EA200701595A EA200701595A EA015615B1 EA 015615 B1 EA015615 B1 EA 015615B1 EA 200701595 A EA200701595 A EA 200701595A EA 200701595 A EA200701595 A EA 200701595A EA 015615 B1 EA015615 B1 EA 015615B1
Authority
EA
Eurasian Patent Office
Prior art keywords
opioid
composition according
composition
amount
matrix
Prior art date
Application number
EA200701595A
Other languages
English (en)
Russian (ru)
Other versions
EA200701595A1 (ru
Inventor
Ричард О. Мэннион
Уильям Х. Маккенна
Эдвард П. О'Доннелл
Хелен Кэтлин Данагер
Джеффри Джерард Хэйз
Хассан Мохаммад
Дерек Аллен Пратер
Харджит Тамбер
Мелколм Уолден
Стив Уайтлок
Вольфганг Флайшер
Удо Хан
Кристоф Спитцлай
Кристиан Лойнер
Original Assignee
Еуро-Селтик С.А.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from PCT/GB2005/050014 external-priority patent/WO2005079760A1/en
Application filed by Еуро-Селтик С.А. filed Critical Еуро-Селтик С.А.
Priority claimed from PCT/EP2006/000727 external-priority patent/WO2006079550A2/en
Publication of EA200701595A1 publication Critical patent/EA200701595A1/ru
Publication of EA015615B1 publication Critical patent/EA015615B1/ru

Links

Classifications

    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
    • B29B9/00—Making granules
    • B29B9/02—Making granules by dividing preformed material
    • B29B9/06—Making granules by dividing preformed material in the form of filamentary material, e.g. combined with extrusion
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2033/00—Use of polymers of unsaturated acids or derivatives thereof as moulding material
    • B29K2033/04—Polymers of esters
    • B29K2033/12—Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0085—Copolymers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Mechanical Engineering (AREA)
  • Rheumatology (AREA)
  • Psychiatry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
EA200701595A 2005-01-28 2006-01-27 Устойчивые к спиртам лекарственные формы EA015615B1 (ru)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
GBGB0501638.1A GB0501638D0 (en) 2005-01-28 2005-01-28 Particulates
PCT/GB2005/050014 WO2005079760A1 (en) 2004-02-12 2005-02-11 Particulates
US67050605P 2005-04-12 2005-04-12
US73033905P 2005-10-26 2005-10-26
PCT/EP2006/000727 WO2006079550A2 (en) 2005-01-28 2006-01-27 Alcohol resistant dosage forms

Publications (2)

Publication Number Publication Date
EA200701595A1 EA200701595A1 (ru) 2008-02-28
EA015615B1 true EA015615B1 (ru) 2011-10-31

Family

ID=34259727

Family Applications (1)

Application Number Title Priority Date Filing Date
EA200701595A EA015615B1 (ru) 2005-01-28 2006-01-27 Устойчивые к спиртам лекарственные формы

Country Status (11)

Country Link
EP (3) EP2289491A1 (enExample)
JP (2) JP5704789B2 (enExample)
CN (1) CN101132772B (enExample)
AP (1) AP2274A (enExample)
EA (1) EA015615B1 (enExample)
GB (1) GB0501638D0 (enExample)
IL (1) IL184858A (enExample)
MA (1) MA29368B1 (enExample)
NZ (2) NZ590772A (enExample)
TN (1) TNSN07293A1 (enExample)
ZA (1) ZA200705913B (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11806433B2 (en) 2017-11-01 2023-11-07 Edgemont Pharmaceuticals, LLC Trust Alcohol-resistant oral pharmaceutical compositions of lorazepam

Families Citing this family (15)

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Publication number Priority date Publication date Assignee Title
US20090317355A1 (en) * 2006-01-21 2009-12-24 Abbott Gmbh & Co. Kg, Abuse resistant melt extruded formulation having reduced alcohol interaction
US20070212414A1 (en) * 2006-03-08 2007-09-13 Penwest Pharmaceuticals Co. Ethanol-resistant sustained release formulations
KR101528957B1 (ko) 2008-09-24 2015-06-17 에보니크 룀 게엠베하 에탄올의 영향에 대하여 내성을 갖는 ｐｈ-의존성 조절 방출 제약학적 오피오이드 조성물
US20110311631A1 (en) * 2009-03-18 2011-12-22 Evonik Röhm Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising a polymer mixture and excipients
JP5619130B2 (ja) * 2009-03-18 2014-11-05 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツングＥｖｏｎｉｋ ＲｏｅｈｍＧｍｂＨ 中性ビニルポリマーおよび賦形剤を含むコーティングを使用するエタノールの影響に対する耐性を有する制御放出性医薬組成物
GB0909680D0 (en) * 2009-06-05 2009-07-22 Euro Celtique Sa Dosage form
SG184523A1 (en) * 2010-05-10 2012-11-29 Euro Celtique Sa Pharmaceutical compositions comprising hydromorphone and naloxone
MX340188B (es) * 2010-05-10 2016-06-30 Euro-Celtique S A * Elaboracion de granulos sin activos y tabletas que comprenden los mismos.
WO2011141490A1 (en) * 2010-05-10 2011-11-17 Euro-Celtique S.A. Combination of active loaded granules with additional actives
GB201020895D0 (en) * 2010-12-09 2011-01-26 Euro Celtique Sa Dosage form
HRP20170864T1 (hr) * 2011-06-01 2017-08-25 Fmc Corporation Čvrsti dozni oblici s kontroliranim oslobađanjem
WO2013057570A2 (en) * 2011-10-18 2013-04-25 Purdue Pharma L.P. Acrylic polymer formulations
LT2838512T (lt) * 2012-04-18 2018-11-12 GrĆ¼nenthal GmbH Pažeidimui atspari ir dozės atpalaidavimo nuokrypiui atspari farmacinė vaisto forma
CA2881144A1 (en) * 2012-11-09 2014-05-09 Purdue Pharma Pharmaceutical compositions comprising hydromorphone and naloxone
PE20151301A1 (es) * 2013-02-05 2015-09-16 Purdue Pharma Lp Formulaciones farmaceuticas resistentes a la manipulacion indebida

Citations (2)

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US5958452A (en) * 1994-11-04 1999-09-28 Euro-Celtique, S.A. Extruded orally administrable opioid formulations
WO2003004009A1 (en) * 2001-07-02 2003-01-16 Geneva Pharmaceuticals, Inc. Pharmaceutical composition

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GB8626098D0 (en) * 1986-10-31 1986-12-03 Euro Celtique Sa Controlled release hydromorphone composition
US5656295A (en) 1991-11-27 1997-08-12 Euro-Celtique, S.A. Controlled release oxycodone compositions
US5266331A (en) 1991-11-27 1993-11-30 Euroceltique, S.A. Controlled release oxycodone compositions
US5968551A (en) 1991-12-24 1999-10-19 Purdue Pharma L.P. Orally administrable opioid formulations having extended duration of effect
NZ260408A (en) * 1993-05-10 1996-05-28 Euro Celtique Sa Controlled release preparation comprising tramadol
DE19710008A1 (de) * 1997-03-12 1998-09-17 Basf Ag Feste, mindestens zweiphasige Zubereitungsformen eines Opioid-Analgeticums mit verzögerter Freisetzung
US6306438B1 (en) * 1997-07-02 2001-10-23 Euro-Celtique, S.A. Stabilized sustained release tramadol formulations
DE19901085C2 (de) * 1999-01-14 2003-12-18 Lohmann Therapie Syst Lts Transdermales therapeutisches System mit einer selbstklebenden Matrix, enthaltend organische Säure-Additionssalze von Alkaloiden des Morphin- bzw. Morphinantyps
US20030118641A1 (en) 2000-07-27 2003-06-26 Roxane Laboratories, Inc. Abuse-resistant sustained-release opioid formulation
SI2283842T1 (sl) * 2000-02-08 2015-07-31 Euro-Celtique S.A. Oralne formulacije opioidnih agonistov, varne pred zlorabo
GB0026137D0 (en) * 2000-10-25 2000-12-13 Euro Celtique Sa Transdermal dosage form
IL160217A0 (en) * 2001-08-06 2004-07-25 Euro Celtique Sa Compositions and methods to prevent abuse of opioids
AU2002319774B2 (en) * 2001-08-06 2005-04-21 Euro-Celtique S.A. Compositions and methods to prevent abuse of opioids
LT2425821T (lt) * 2002-04-05 2017-07-25 Euro-Celtique S.A. Farmacinis preparatas, turintis oksikodono ir naloksono
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JP5189242B2 (ja) * 2002-09-23 2013-04-24 アルケルメス ファーマ アイルランド リミテッド 乱用抵抗性の医薬組成物
EP2218448B1 (en) * 2002-12-13 2015-09-23 Durect Corporation Oral drug delivery system comprising high viscosity liquid carrier materials
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TWI357815B (en) * 2003-06-27 2012-02-11 Euro Celtique Sa Multiparticulates
TWI350762B (en) * 2004-02-12 2011-10-21 Euro Celtique Sa Particulates

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5958452A (en) * 1994-11-04 1999-09-28 Euro-Celtique, S.A. Extruded orally administrable opioid formulations
EP1348429A2 (en) * 1994-11-04 2003-10-01 Euro-Celtique S.A. Melt-extruded orally administrable opioid formulations
WO2003004009A1 (en) * 2001-07-02 2003-01-16 Geneva Pharmaceuticals, Inc. Pharmaceutical composition

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11806433B2 (en) 2017-11-01 2023-11-07 Edgemont Pharmaceuticals, LLC Trust Alcohol-resistant oral pharmaceutical compositions of lorazepam

Also Published As

Publication number Publication date
IL184858A0 (en) 2007-12-03
CN101132772B (zh) 2012-05-09
IL184858A (en) 2016-03-31
EP3228308A1 (en) 2017-10-11
JP2013100306A (ja) 2013-05-23
JP5704789B2 (ja) 2015-04-22
MA29368B1 (fr) 2008-04-01
NZ590772A (en) 2012-05-25
AP2007004099A0 (en) 2007-08-31
GB0501638D0 (en) 2005-03-02
CN101132772A (zh) 2008-02-27
JP2008528534A (ja) 2008-07-31
AP2274A (en) 2011-08-19
EP2319499A1 (en) 2011-05-11
TNSN07293A1 (fr) 2008-12-31
NZ560669A (en) 2012-09-28
EA200701595A1 (ru) 2008-02-28
EP2289491A1 (en) 2011-03-02
ZA200705913B (en) 2008-08-27

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): BY KZ