CY1120668T1 - Σταθερη υπο πιεση συνθεση διαλυματος αερολυματος συνδυασμου βρωμιουχου γλυκοπυρρονιου και φορμοτερολης - Google Patents
Σταθερη υπο πιεση συνθεση διαλυματος αερολυματος συνδυασμου βρωμιουχου γλυκοπυρρονιου και φορμοτεροληςInfo
- Publication number
- CY1120668T1 CY1120668T1 CY181100949T CY181100949T CY1120668T1 CY 1120668 T1 CY1120668 T1 CY 1120668T1 CY 181100949 T CY181100949 T CY 181100949T CY 181100949 T CY181100949 T CY 181100949T CY 1120668 T1 CY1120668 T1 CY 1120668T1
- Authority
- CY
- Cyprus
- Prior art keywords
- formoterol
- combination
- fluticasone
- glycopyrrone
- aerosyme
- Prior art date
Links
Classifications
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
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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
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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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
- A61K31/56—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
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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
- A61K31/56—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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- 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
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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
- A61K47/02—Inorganic compounds
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
- A61K9/124—Aerosols; Foams characterised by the propellant
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0065—Inhalators with dosage or measuring devices
- A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
- A61M15/007—Mechanical counters
- A61M15/0071—Mechanical counters having a display or indicator
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0086—Inhalation chambers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M2039/226—Spindles or actuating means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Dispersion Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Biophysics (AREA)
- Inorganic Chemistry (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)
Abstract
Η εφεύρεση αφορά μία σύνθεση διαλύματος αερολύματος που προορίζεται για χρήση με έναν εισπνευστήρα υπολογισμένης δόσης υπό πίεση που περιλαμβάνει βρωμιούχο γλυκοπυρρόνιο και φορμοτερόλη, ή ένα άλας αυτής ή ένα επιδιαλύτωμα του εν λόγω άλατος, ενδεχομένως σε συνδυασμό με ένα ή περισσότερα επιπλέον δραστικά συστατικά, σταθεροποιημένη δια μίας επιλεγμένης ποσότητας ανόργανου οξέος και όπου η ποσότητα του προϊόντος αποδόμησης Ν-(3-βρωμο)-[2-υδροξυ-5-[1-υδροξυ-2-[1-(4-μεθοξυφαινυλ)προπαν-2-υλαμινο]αιθυλ]φαινυλ]φορμαμίδιο είναι χαμηλότερη από το όριο ποσοτικού προσδιορισμού, όταν αποθηκεύεται υπό επιταχυνόμενες συνθήκες σε 25°C και 60% σχετική υγρασία (Σ.Υ.) επί 6 μήνες εντός ενός δοχείου εσωτερικά επενδεδυμένου με μία ρητίνη που περιλαμβάνει ένα πολυμερές φθοριωμένου αιθυλενοπροπυλενίου (FEP). Το ενδεχομένως ένα ή περισσότερα δραστικά συστατικά μπορεί να είναι ένα εισπνεύσιμο κορτικοστεροειδές που επιλέγεται από διπροπιονική βεκλομεθαζόνη, βουδεσονίδη ή το 22R-επιμερές αυτής, κικλεσονίδη,φλουνισολίδη, προπιονική φλουτικαζόνη, φουροϊκή φλουτικαζόνη, φουροϊκή μομεταζόνη, κτλ.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP13199784 | 2013-12-30 | ||
PCT/EP2014/079259 WO2015101576A1 (en) | 2013-12-30 | 2014-12-23 | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
EP14825154.9A EP3089735B1 (en) | 2013-12-30 | 2014-12-23 | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
Publications (1)
Publication Number | Publication Date |
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CY1120668T1 true CY1120668T1 (el) | 2019-12-11 |
Family
ID=49886777
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CY181100949T CY1120668T1 (el) | 2013-12-30 | 2018-09-11 | Σταθερη υπο πιεση συνθεση διαλυματος αερολυματος συνδυασμου βρωμιουχου γλυκοπυρρονιου και φορμοτερολης |
Country Status (34)
Country | Link |
---|---|
US (2) | US10596113B2 (el) |
EP (3) | EP3089735B1 (el) |
JP (2) | JP6563950B2 (el) |
KR (2) | KR101861117B1 (el) |
CN (2) | CN105848641B (el) |
AR (1) | AR098982A1 (el) |
AU (1) | AU2014375301B2 (el) |
BR (1) | BR112016014583B1 (el) |
CA (1) | CA2935305C (el) |
CL (1) | CL2016001653A1 (el) |
CY (1) | CY1120668T1 (el) |
DK (1) | DK3089735T3 (el) |
EA (1) | EA033227B1 (el) |
ES (1) | ES2687345T3 (el) |
HK (1) | HK1225313A1 (el) |
HR (1) | HRP20181551T1 (el) |
HU (1) | HUE039513T2 (el) |
IL (1) | IL246498B (el) |
LT (1) | LT3089735T (el) |
MA (1) | MA39155A1 (el) |
MX (1) | MX368835B (el) |
MY (1) | MY182861A (el) |
PE (1) | PE20160997A1 (el) |
PH (1) | PH12016501268B1 (el) |
PL (1) | PL3089735T3 (el) |
PT (1) | PT3089735T (el) |
RS (1) | RS57687B1 (el) |
SA (1) | SA516371427B1 (el) |
SG (1) | SG11201605311UA (el) |
SI (1) | SI3089735T1 (el) |
TN (1) | TN2016000261A1 (el) |
TW (1) | TWI660747B (el) |
UA (1) | UA117845C2 (el) |
WO (1) | WO2015101576A1 (el) |
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CA2785349C (en) * | 2009-12-23 | 2018-07-03 | Chiesi Farmaceutici S.P.A. | Combination therapy for copd |
TWI495468B (zh) | 2009-12-23 | 2015-08-11 | Chiesi Farma Spa | 治療慢性阻塞性肺病(copd)之醫藥組成物 |
PE20121467A1 (es) | 2009-12-23 | 2012-11-07 | Chiesi Farma Spa | Formulacion de aerosol para la enfermedad pulmonar obstructiva cronica |
SI3096737T1 (en) | 2013-12-30 | 2018-07-31 | Chiesi Farmaceutici S.P.A. | Stable aerosol pressure solution containing glycopyrione bromide and formoterol |
LT3089735T (lt) * | 2013-12-30 | 2018-09-10 | Chiesi Farmaceutici S.P.A. | Glikopironio bromido ir formoterolio derinio stabili suslėgta aerozolinė tirpalo kompozicija |
WO2017093758A1 (en) | 2015-12-04 | 2017-06-08 | Mexichem Fluor S.A. De C.V. | Pharmaceutical composition |
GB2545025A (en) * | 2015-12-04 | 2017-06-07 | Mexichem Fluor Sa De Cv | Pharmaceutical composition |
US10098837B2 (en) * | 2016-07-28 | 2018-10-16 | Chiesi Farmaceutici S.P.A. | Combination therapy for COPD |
JP6781829B2 (ja) | 2016-09-19 | 2020-11-04 | メキシケム フロー エセ・ア・デ・セ・ヴェ | 医薬組成物 |
CN107233311B (zh) * | 2017-06-27 | 2020-12-04 | 长风药业股份有限公司 | 一种以阿福特罗和格隆溴铵为活性成分的雾化剂及其制备方法 |
WO2020084549A1 (en) * | 2018-10-25 | 2020-04-30 | Glenmark Specialty S.A. | Nebulization composition comprising glycopyrrolate and formoterol |
US20220241524A1 (en) * | 2019-07-12 | 2022-08-04 | Kindeva Drug Delivery L.P. | Aerosol formulation, canister, and inhaler containing the formulation, and method of use |
MX2022004781A (es) | 2019-12-02 | 2022-05-16 | Chiesi Farm Spa | Lata de acero inoxidable para inhaladores dosificadores presurizados. |
AU2021213883A1 (en) * | 2020-01-28 | 2022-07-21 | Chiesi Farmaceutici S.P.A. | Pressurised metered dose inhalers comprising a buffered pharmaceutical formulation |
CN113274596A (zh) | 2020-02-20 | 2021-08-20 | 奇斯药制品公司 | 包含缓冲药物制剂的加压定量吸入器 |
CN115989032A (zh) | 2020-07-31 | 2023-04-18 | 化学研究有限公司 | 用于吸入施用的组合疗法 |
CN112051346A (zh) * | 2020-09-24 | 2020-12-08 | 珠海瑞思普利生物制药有限公司 | 一种同时测定茚达特罗和格隆溴铵含量的hplc方法 |
KR20230084482A (ko) | 2020-10-09 | 2023-06-13 | 키에시 파르마슈티시 엣스. 피. 에이. | 가압 정량 흡입기를 위한 약제학적 제제 |
WO2023117985A1 (en) * | 2021-12-21 | 2023-06-29 | Chiesi Farmaceutici S.P.A. | Dry powder formulations filled in an inhaler with improved resistance to humidity |
WO2023227782A1 (en) | 2022-05-27 | 2023-11-30 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
WO2023227783A1 (en) | 2022-05-27 | 2023-11-30 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
WO2023227781A1 (en) | 2022-05-27 | 2023-11-30 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
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GB0523656D0 (en) | 2005-11-21 | 2005-12-28 | Novartis Ag | Organic compounds |
GB0523655D0 (en) | 2005-11-21 | 2005-12-28 | Novartis Ag | Organic compounds |
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CA2785349C (en) | 2009-12-23 | 2018-07-03 | Chiesi Farmaceutici S.P.A. | Combination therapy for copd |
PE20121467A1 (es) | 2009-12-23 | 2012-11-07 | Chiesi Farma Spa | Formulacion de aerosol para la enfermedad pulmonar obstructiva cronica |
TWI495468B (zh) * | 2009-12-23 | 2015-08-11 | Chiesi Farma Spa | 治療慢性阻塞性肺病(copd)之醫藥組成物 |
CN103079618B (zh) | 2010-09-06 | 2015-12-02 | 奇斯药制品公司 | 定量吸入器致动器、定量吸入器 |
WO2012158166A1 (en) * | 2011-05-17 | 2012-11-22 | Pearl Therapeutics, Inc. | Compositions, methods & systems for respiratory delivery of two or more active agents |
EA033581B1 (ru) | 2012-08-29 | 2019-11-06 | Chiesi Farm Spa | Аэрозольное ингаляционное устройство |
SI3096737T1 (en) * | 2013-12-30 | 2018-07-31 | Chiesi Farmaceutici S.P.A. | Stable aerosol pressure solution containing glycopyrione bromide and formoterol |
LT3089735T (lt) * | 2013-12-30 | 2018-09-10 | Chiesi Farmaceutici S.P.A. | Glikopironio bromido ir formoterolio derinio stabili suslėgta aerozolinė tirpalo kompozicija |
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