NO306449B1 - Oralt administrerbart morfinpreparat for vedvarende frigiving samt fremstilling av multipartikler for bruk i preparatet - Google Patents

Oralt administrerbart morfinpreparat for vedvarende frigiving samt fremstilling av multipartikler for bruk i preparatet

Info

Publication number
NO306449B1
NO306449B1 NO942470A NO942470A NO306449B1 NO 306449 B1 NO306449 B1 NO 306449B1 NO 942470 A NO942470 A NO 942470A NO 942470 A NO942470 A NO 942470A NO 306449 B1 NO306449 B1 NO 306449B1
Authority
NO
Norway
Prior art keywords
morphine
preparation
sustained release
acceptable salt
pharmaceutically acceptable
Prior art date
Application number
NO942470A
Other languages
English (en)
Norwegian (no)
Other versions
NO942470L (no
NO942470D0 (no
Inventor
Joanne Heafield
Trevor John Knott
Stewart Thomas Leslie
Sandra Therese A Malkowska
Ronald Brown Miller
Derek Allan Prater
Kevin John Smith
Mark Chasin
Paul Goldenheim
Benjamin Oshlack
Frank Pedi Jr
Richard Sackler
Robert Kaiko
Original Assignee
Euro Celtique Sa
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27547204&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NO306449(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from GB9315467A external-priority patent/GB2281204A/en
Priority claimed from GB9324045A external-priority patent/GB2284760B/en
Priority claimed from GB9403922A external-priority patent/GB2288117A/en
Priority claimed from GB9404928A external-priority patent/GB2287880A/en
Application filed by Euro Celtique Sa filed Critical Euro Celtique Sa
Publication of NO942470D0 publication Critical patent/NO942470D0/no
Publication of NO942470L publication Critical patent/NO942470L/no
Publication of NO306449B1 publication Critical patent/NO306449B1/no

Links

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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • 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
    • A61K9/1617—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
    • A61K9/14—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
    • A61K9/20—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
    • A61K9/205—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
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Saccharide Compounds (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
NO942470A 1993-07-01 1994-06-30 Oralt administrerbart morfinpreparat for vedvarende frigiving samt fremstilling av multipartikler for bruk i preparatet NO306449B1 (no)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US8624893A 1993-07-01 1993-07-01
GB9315467A GB2281204A (en) 1993-07-27 1993-07-27 Sustained release morphine compositions
US13350393A 1993-10-07 1993-10-07
GB9324045A GB2284760B (en) 1993-11-23 1993-11-23 A method of preparing pharmaceutical compositions by melt pelletisation
GB9403922A GB2288117A (en) 1994-03-01 1994-03-01 Sustained release morphine
GB9404928A GB2287880A (en) 1994-03-14 1994-03-14 Production of sustained release compositions

Publications (3)

Publication Number Publication Date
NO942470D0 NO942470D0 (no) 1994-06-30
NO942470L NO942470L (no) 1995-01-02
NO306449B1 true NO306449B1 (no) 1999-11-08

Family

ID=27547204

Family Applications (1)

Application Number Title Priority Date Filing Date
NO942470A NO306449B1 (no) 1993-07-01 1994-06-30 Oralt administrerbart morfinpreparat for vedvarende frigiving samt fremstilling av multipartikler for bruk i preparatet

Country Status (17)

Country Link
EP (1) EP0636370B2 (cs)
JP (1) JP3647897B2 (cs)
KR (1) KR100365572B1 (cs)
AT (1) ATE172376T1 (cs)
AU (2) AU6610594A (cs)
CA (1) CA2127166C (cs)
CZ (1) CZ287918B6 (cs)
DE (1) DE69414046T3 (cs)
DK (1) DK0636370T4 (cs)
ES (1) ES2124372T5 (cs)
FI (1) FI114285B (cs)
HU (1) HU220075B (cs)
IL (1) IL109944A (cs)
NO (1) NO306449B1 (cs)
PL (1) PL179282B1 (cs)
SG (1) SG50706A1 (cs)
SK (1) SK280534B6 (cs)

Families Citing this family (65)

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US5891471A (en) 1993-11-23 1999-04-06 Euro-Celtique, S.A. Pharmaceutical multiparticulates
US5843480A (en) 1994-03-14 1998-12-01 Euro-Celtique, S.A. Controlled release diamorphine formulation
GB9422154D0 (en) 1994-11-03 1994-12-21 Euro Celtique Sa Pharmaceutical compositions and method of producing the same
US5965161A (en) 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
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DE19732903A1 (de) 1997-07-30 1999-02-04 Falk Pharma Gmbh Pellet-Formulierung zur Behandlung des Intestinaltraktes
US6066339A (en) * 1997-10-17 2000-05-23 Elan Corporation, Plc Oral morphine multiparticulate formulation
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US8524277B2 (en) 1998-03-06 2013-09-03 Alza Corporation Extended release dosage form
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DE19918325A1 (de) 1999-04-22 2000-10-26 Euro Celtique Sa Verfahren zur Herstellung von Arzneiformen mit regulierter Wirkstofffreisetzung mittels Extrusion
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US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
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US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
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EA014739B1 (ru) 2005-09-09 2011-02-28 Лабофарм Инк. Композиция тразодона для введения один раз в день
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
RU2493830C2 (ru) 2008-01-25 2013-09-27 Грюненталь Гмбх Лекарственная форма
US9226907B2 (en) 2008-02-01 2016-01-05 Abbvie Inc. Extended release hydrocodone acetaminophen and related methods and uses thereof
CA2723438C (en) 2008-05-09 2016-10-11 Gruenenthal Gmbh Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
NZ592049A (en) 2008-10-03 2012-11-30 Falk Pharma Gmbh Compositions and methods for the treatment of bowel diseases with granulated mesalamine
ES2534908T3 (es) 2009-07-22 2015-04-30 Grünenthal GmbH Forma de dosificación de liberación controlada extruida por fusión en caliente
KR20120050975A (ko) 2009-07-22 2012-05-21 그뤼넨탈 게엠베하 산화-민감성 오피오이드를 위한 내변조성 용량형
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AR082862A1 (es) 2010-09-02 2013-01-16 Gruenenthal Gmbh Forma de dosificacion resistente a alteracion que comprende un polimero anionico
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PL2736495T3 (pl) 2011-07-29 2018-01-31 Gruenenthal Gmbh Tabletka odporna na ingerencję, zapewniająca natychmiastowe uwalnianie leku
DK2736497T3 (da) 2011-07-29 2017-11-13 Gruenenthal Gmbh Stød-resistent tablet, der tilvejebringer en øjeblikkelig frigivelse af et lægemiddel.
MX356421B (es) 2012-02-28 2018-05-29 Gruenenthal Gmbh Forma de dosificacion resistente a la manipulacion indebida que comprende un compuesto farmacologicamente activo y un polimero anionico.
PL2838512T3 (pl) 2012-04-18 2018-12-31 Grünenthal GmbH Farmaceutyczna postać dawkowania odporna na niewłaściwe użycie i odporna na uderzeniowe uwalnianie dawki
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
AR096439A1 (es) 2013-05-29 2015-12-30 Gruenenthal Gmbh Forma de dosificación resistente al uso indebido que contiene una o más partículas
JP6445537B2 (ja) 2013-05-29 2018-12-26 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング １個または複数の粒子を含有する改変防止（ｔａｍｐｅｒ−ｒｅｓｉｓｔａｎｔ）剤形
CN105682643B (zh) 2013-07-12 2019-12-13 格吕伦塔尔有限公司 含有乙烯-醋酸乙烯酯聚合物的防篡改剂型
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DK0636370T3 (da) 1999-06-28
FI943141A7 (fi) 1995-01-02
DE69414046D1 (de) 1998-11-26
ATE172376T1 (de) 1998-11-15
ES2124372T3 (es) 1999-02-01
PL179282B1 (pl) 2000-08-31
AU5299598A (en) 1998-03-26
JPH07149648A (ja) 1995-06-13
CA2127166A1 (en) 1995-01-02
PL304062A1 (en) 1995-01-09
NO942470L (no) 1995-01-02
DK0636370T4 (da) 2004-04-19
CZ155094A3 (en) 1995-01-18
JP3647897B2 (ja) 2005-05-18
IL109944A (en) 1998-12-06
KR100365572B1 (ko) 2003-07-02
SG50706A1 (en) 1998-07-20
IL109944A0 (en) 1994-10-07
FI114285B (fi) 2004-09-30
SK280534B6 (sk) 2000-03-13
HUT70938A (en) 1995-11-28
HU220075B (hu) 2001-10-28
EP0636370A1 (en) 1995-02-01
CZ287918B6 (cs) 2001-03-14
HU9402007D0 (en) 1994-09-28
AU722358B2 (en) 2000-07-27
DE69414046T3 (de) 2004-08-26
DE69414046T2 (de) 1999-04-22
EP0636370B1 (en) 1998-10-21
AU6610594A (en) 1995-01-12
EP0636370B2 (en) 2004-01-02
NO942470D0 (no) 1994-06-30
CA2127166C (en) 2006-03-14
FI943141A0 (fi) 1994-06-30
KR950002762A (ko) 1995-02-16
SK76394A3 (en) 1995-08-09
ES2124372T5 (es) 2004-07-16

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