HRP20200495T1 - Sastavi za liječenje gastrointestinalne upale - Google Patents

Sastavi za liječenje gastrointestinalne upale Download PDF

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Publication number
HRP20200495T1
HRP20200495T1 HRP20200495TT HRP20200495T HRP20200495T1 HR P20200495 T1 HRP20200495 T1 HR P20200495T1 HR P20200495T T HRP20200495T T HR P20200495TT HR P20200495 T HRP20200495 T HR P20200495T HR P20200495 T1 HRP20200495 T1 HR P20200495T1
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Croatia
Prior art keywords
esophagitis
pharmaceutical composition
oral pharmaceutical
use according
disease
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HRP20200495TT
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English (en)
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Elaine Phillips
Malcolm Hill
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Meritage Pharma, Inc.
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Application filed by Meritage Pharma, Inc. filed Critical Meritage Pharma, Inc.
Publication of HRP20200495T1 publication Critical patent/HRP20200495T1/hr

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    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/341—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • A—HUMAN NECESSITIES
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    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
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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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P1/12—Antidiarrhoeals
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • 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
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/44—Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
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  • Endocrinology (AREA)
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  • Dispersion Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Biochemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Immunology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines Containing Plant Substances (AREA)

Claims (10)

1. Oralni farmaceutski sastav za upotrebu u liječenju, prevenciji ili ublažavanju upale jednjaka ili s time povezanih simptoma, sastav obuhvaća: kortikosteriod, maltodekstrin, i smjesu karboksimetil celuloze (CMC) i mikrokristalne celuloze (MCC).
2. Oralni farmaceutski sastav za upotrebu prema zahtjevu 1, gdje je kortikosteriod aklometazon, amcinomid, beklometazon, betametazon, budezonid, ciklezonid, klobetazol, klobetazon, klokortolon, kloprednol, kortivazol, deflazakort, dezoksikortikosteron, dezonid, deksametazon, diflorazon, diflukortolon, difluprednat, fluklorolon, fludrokortizon, fludroksikortid, flumetazon, flunizolid, fluocinolon acetonid, fluocinonid, fluokortin, fluokortolon, fluorometolon, fluperolon, flutikazon, fupredniden, formokortal, halcinonid, halometazon, hidrokortizon aceponat, hidrokortizon buteprat, hidrokortizon butirat, loteprednol, medrizon, meprednizon, metilprednizolon, metilprednizolon aceponat, mometazon, parametazon, prednikarbat, prednizon, prednizolon, predniliden, remeksolon, tiksokortol, triamcinolon ili ulobetazol, ili njegova farmaceutski prihvatljiva sol ili ester, ili kombinacije gore navedenog.
3. Oralni farmaceutski sastav za upotrebu prema zahtjevu 1, gdje je kortikosteroid lokalno aktivni kortikosteroid, opcionalno gdje je lokalno aktivni kortikosteriod budezonid.
4. Oralni farmaceutski sastav za upotrebu prema zahtjevu 1 koji ima viskoznost najmanje 0.005 Pa.s (5 cP) na 25 °C s brzinom smicanja od oko 13.2 sek-1.
5. Oralni farmaceutski sastav za upotrebu prema bilo kojem od zahtjeva 1-4, gdje je upala jednjaka upala koja je povezana s eozinofilnim ezofagitisom, upalnom bolesti crijeva koja obuhvaća jednjak, Crohnovom bolesti, celijakijom, proksimalnom gastrointestinalnom patologijom, eozinofilnom gastrointestinalnom upalom, epitelnom hiperplazijom, hiperplazijom bazalnih stanica, uvećanim papilama, proširenim krvnim žilama u papilama, gljivičnim ezofagitisom, virusnim ezofagitisom, bakterijskim ezofagitisom, korozivnim ezofagitisom, radijacijskim ezofagitisom, kemoterapijskim ezofagitisom, bolesti presatka protiv primatelja, kožnom bolesti koja zahvaća jednjak, buloznim pemfigoidom, vulgarnim pemfigusom, buloznom epidermolizom, Stevens-Johnsonovim sindromom, Behcetovom bolesti, sarkoidozom, idiopatskom ezofagitisom, eozinofilnim gastritisom, Menetrierovom bolesti, parazitskim gastritisom, limfocitnim ezofagitisom, ezofagitisom povezanim s upalnom bolesti crijeva, parazitskim gastritisom, limfocitnim ezofagitisom, ezofagitisom povezanim s upalnom bolesti crijeva, eozinofilnim duodenitisom, duodenalnom eozinofilijom, funkcionalnom dispepsijom, intermedijarnim ezofagitisom, upalom jednjaka sekundarnim kaustičnim/nadražujućim gutanjem, postojanim/ponavljajućim suženjem jednjaka bilo kojeg uzroka i uključujući kaustično/nadražujuće gutanje, ezofagitisom induciranim tabletama, sistemskim bolestima, kongenitalnim bolestima, post-operativnom upalom, ili gastroenteritisom.
6. Oralni farmaceutski sastav za upotrebu prema bilo kojem od zahtjeva 1-5, gdje je upala jednjaka povezana s eozinofilnim ezofagitisom.
7. Oralni farmaceutski sastav za upotrebu prema bilo kojem od zahtjeva 1-5, gdje je upala jednjaka povezana s Barrettovim jednjakom, gastroezofagealnom refluksnom bolesti (GERD), neerozivnom refluksnom bolesti (NERD), ili erozivnim ezofagitisom.
8. Oralni farmaceutski sastav za upotrebu prema zahtjevu 1, korišten za davanje 0.1 mg do 20 mg kortikosteroida dnevno pojedincu kojem je potrebno, opcionalno koji se koristi za davanje 0.3 mg do 5 mg kortikosteroida dnevno pojedincu kojem je to potrebno.
9. Oralni farmaceutski sastav za upotrebu prema zahtjevu 1, gdje je farmaceutski sastav volumena 1 mL do 20 mL.
10. Oralni farmaceutski sastav za upotrebu prema zahtjevu 1, gdje je oralni farmaceutski sastav tableta za otapanje, pločica za otapanje, kapsula, gel kapsula, tekućina, polu-čvrsta supstanca, čvrsta supstanca, gel, matrica gela, krema, ili pasta.
HRP20200495TT 2007-11-13 2020-03-26 Sastavi za liječenje gastrointestinalne upale HRP20200495T1 (hr)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US98772007P 2007-11-13 2007-11-13
US1201207P 2007-12-06 2007-12-06
US1599807P 2007-12-21 2007-12-21
US1981808P 2008-01-08 2008-01-08
US3494108P 2008-03-07 2008-03-07
US3534808P 2008-03-10 2008-03-10
US5410608P 2008-05-16 2008-05-16
US5410708P 2008-05-16 2008-05-16
US5410308P 2008-05-16 2008-05-16
US5410408P 2008-05-16 2008-05-16
US5410508P 2008-05-16 2008-05-16
US9056808P 2008-08-20 2008-08-20
EP17210162.8A EP3354276B1 (en) 2007-11-13 2008-11-12 Compositions for the treatment of gastrointestinal inflammation

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HRP20200495T1 true HRP20200495T1 (hr) 2020-06-26

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HRP20180408TT HRP20180408T1 (hr) 2007-11-13 2018-03-08 Pripravci za liječenje gastrointestinalnih upala
HRP20200495TT HRP20200495T1 (hr) 2007-11-13 2020-03-26 Sastavi za liječenje gastrointestinalne upale

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US (5) US20090149433A1 (hr)
EP (7) EP3354276B1 (hr)
JP (6) JP2011503113A (hr)
KR (1) KR101245604B1 (hr)
AU (3) AU2008321395B2 (hr)
CA (5) CA2704943A1 (hr)
CY (2) CY1120048T1 (hr)
DK (4) DK2214679T3 (hr)
ES (5) ES2908290T3 (hr)
GB (1) GB2458403B (hr)
HK (1) HK1256861A1 (hr)
HR (2) HRP20180408T1 (hr)
HU (1) HUE038452T2 (hr)
IL (5) IL205548A0 (hr)
LT (2) LT2211896T (hr)
MX (1) MX349677B (hr)
NZ (1) NZ585268A (hr)
PL (3) PL2211896T3 (hr)
PT (4) PT2214679T (hr)
RU (1) RU2491074C2 (hr)
SI (2) SI2211896T1 (hr)
WO (5) WO2009064457A2 (hr)
ZA (1) ZA201003358B (hr)

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