AR098982A1 - Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosol - Google Patents
Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosolInfo
- Publication number
- AR098982A1 AR098982A1 ARP140104938A ARP140104938A AR098982A1 AR 098982 A1 AR098982 A1 AR 098982A1 AR P140104938 A ARP140104938 A AR P140104938A AR P140104938 A ARP140104938 A AR P140104938A AR 098982 A1 AR098982 A1 AR 098982A1
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- Prior art keywords
- aerosol
- dosage
- salt
- pharmaceutical composition
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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
- A61K9/124—Aerosols; Foams characterised by the propellant
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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
- 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)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (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)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Dispersion Chemistry (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pain & Pain Management (AREA)
- Otolaryngology (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
Reivindicación 1: Una composición farmacéutica en solución para aerosol para utilizar en un inhalador presurizado de dosis medida caracterizada porque comprende: (a) bromuro de glicopirronio con una dosificación dentro del rango entre 5 y 26 mg por accionamiento; (b) formoterol, o una sal del mismo o un solvato de dicha sal, con una dosificación dentro del rango entre 1 y 25 mg por accionamiento; (c) un propelente que consiste en un HFA, (d) un co-solvente; (e) una cantidad útil como estabilizante de un acido mineral, donde dicha composición está contenida en una lata de aerosol recubierta internamente por una resina que comprende un copolímero de etileno-propileno fluorado (FEP). Reivindicación 2: Una composición farmacéutica en solución para aerosol de acuerdo con la reivindicación 1 caracterizada porque la cantidad del producto de degradación N-(3-bromo)-[2-hidroxi-5-[1-hidroxi-2-[1-(4-metoxifenil)propan-2-ilamino]etil]fenil]formamida (DP3), es menor al 0,10% peso en peso con respecto al contenido teórico de fumarato de formoterol de 6 mg/accionamiento, cuando se almacena en condiciones de envejecimiento acelerado a 25ºC y 60% de humedad relativa durante por lo menos 6 meses. Reivindicación 10: Una composición farmacéutica en solución para aerosol de acuerdo con la reivindicación 9 caracterizada porque el corticoesteroide para inhalación se selecciona entre el grupo de: dipropionato de beclometasona, budesonida o su epímero 22R-, ciclesonida, flunisolida, propionato de fluticasona, furoato de fluticasona, furoato de mometasona, butixocort, triamcinolona acetonida, triamcinolona, metilprednisolona, prednisona, loteprednol y rofleponida. Reivindicación 15: Una lata de aerosol recubierta internamente por una resina que comprende un copolímero de etileno-propileno fluorado (FEP) para utilizar con una composición farmacéutica en solución para aerosol para utilizar en un inhalador presurizado de dosis medida caracterizada porque comprende: (a) bromuro de glicopirronio con una dosificación dentro del rango entre 5 y 26 mg por accionamiento; (b) formoterol, o una sal del mismo o un solvato de dicha sal, con una dosificación dentro del rango entre 1 y 25 mg por accionamiento; (c) un propelente que consiste en un HFA, (d) un co-solvente; (e) una cantidad útil como estabilizante de un ácido mineral, y, opcionalmente, (f) un corticoesteroide para inhalación. Reivindicación 16: Un método para reducir la cantidad del producto de degradación N-(3-bromo)-[2-hidroxi-5-[1-hidroxi-2-[1-(4-metoxifenil)propan-2 ilamino]etil]fenil]formamida (DP3) durante la vida de estante de una composición farmacéutica en solución para aerosol para utilizar en un inhalador presurizado de dosis medida que comprende: (a) bromuro de glicopirronio con una dosificación dentro del rango entre 5 y 26 mg por accionamiento; (b) formoterol, o una sal del mismo o un solvato de dicha sal, con una dosificación dentro del rango entre 1 y 25 mg por accionamiento; (c) un propelente que consiste en un HFA, (d) un co-solvente; (e) una cantidad útil como estabilizante de un ácido mineral, y, opcionalmente, (f) un corticoesteroide para inhalación caracterizado porque dicho método comprende envasar la anterior composición en una lata de aerosol recubierta internamente por una resina que comprende un copolímero de etileno-propileno fluorado (FEP). Reivindicación 19: Uso de la composición farmacéutica en solución para aerosol que se define en cualquiera de las reivindicaciones 1 a 14 caracterizado porque es para la prevención y/o el tratamiento de un trastorno respiratorio obstructivo que se selecciona entre asma y EPOC.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP13199784 | 2013-12-30 |
Publications (1)
Publication Number | Publication Date |
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AR098982A1 true AR098982A1 (es) | 2016-06-22 |
Family
ID=49886777
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP140104938A AR098982A1 (es) | 2013-12-30 | 2014-12-29 | Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosol |
Country Status (34)
Country | Link |
---|---|
US (2) | US10596113B2 (es) |
EP (3) | EP3384898A1 (es) |
JP (2) | JP6563950B2 (es) |
KR (2) | KR101861117B1 (es) |
CN (2) | CN105848641B (es) |
AR (1) | AR098982A1 (es) |
AU (1) | AU2014375301B2 (es) |
BR (1) | BR112016014583B1 (es) |
CA (1) | CA2935305C (es) |
CL (1) | CL2016001653A1 (es) |
CY (1) | CY1120668T1 (es) |
DK (1) | DK3089735T3 (es) |
EA (1) | EA033227B1 (es) |
ES (1) | ES2687345T3 (es) |
HK (1) | HK1225313A1 (es) |
HR (1) | HRP20181551T1 (es) |
HU (1) | HUE039513T2 (es) |
IL (1) | IL246498B (es) |
LT (1) | LT3089735T (es) |
MA (1) | MA39155A1 (es) |
MX (1) | MX368835B (es) |
MY (1) | MY182861A (es) |
PE (1) | PE20160997A1 (es) |
PH (1) | PH12016501268A1 (es) |
PL (1) | PL3089735T3 (es) |
PT (1) | PT3089735T (es) |
RS (1) | RS57687B1 (es) |
SA (1) | SA516371427B1 (es) |
SG (1) | SG11201605311UA (es) |
SI (1) | SI3089735T1 (es) |
TN (1) | TN2016000261A1 (es) |
TW (1) | TWI660747B (es) |
UA (1) | UA117845C2 (es) |
WO (1) | WO2015101576A1 (es) |
Families Citing this family (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MY156950A (en) | 2009-12-23 | 2016-04-15 | Chiesi Farma Spa | Aerosol formulation for copd |
WO2011076841A2 (en) * | 2009-12-23 | 2011-06-30 | Chiesi Farmaceutici S.P.A. | Combination therapy for copd |
KR101757951B1 (ko) | 2009-12-23 | 2017-07-13 | 키에시 파르마슈티시 엣스. 피. 에이. | Copd용 조합요법 |
EP3384898A1 (en) * | 2013-12-30 | 2018-10-10 | Chiesi Farmaceutici S.p.A. | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
LT3096737T (lt) | 2013-12-30 | 2018-06-11 | Chiesi Farmaceutici S.P.A. | Stabili glikopironio bromido ir formoterolio derinio suspausto aerozolio tirpalo kompozicija |
GB2545025A (en) * | 2015-12-04 | 2017-06-07 | Mexichem Fluor Sa De Cv | Pharmaceutical composition |
CN112472689B (zh) | 2015-12-04 | 2023-01-17 | 墨西哥氟石股份公司 | 药物组合物 |
US10098837B2 (en) * | 2016-07-28 | 2018-10-16 | Chiesi Farmaceutici S.P.A. | Combination therapy for COPD |
CA3037092C (en) | 2016-09-19 | 2022-06-21 | Mexichem Fluor S.A. De C.V. | Stable pharmaceutical compositions comprising glycopyrrolate and 1,1-difluoroethane (hfa-152a) suitable for use in metered dose inhalers (mdis) |
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 |
PE20221439A1 (es) | 2019-12-02 | 2022-09-21 | Chiesi Farm Spa | Lata de acero inoxidable para inhaladores dosificadores presurizados |
US20230347080A1 (en) | 2020-01-28 | 2023-11-02 | Chiesi Farmaceutici S.P.A | Pressured metered dose inhalers comprising a buffered pharmaceutical formulation |
CN115087431A (zh) * | 2020-02-20 | 2022-09-20 | 奇斯药制品公司 | 包含缓冲药物制剂的加压定量吸入器 |
EP4188327A1 (en) | 2020-07-31 | 2023-06-07 | Chemo Research, S.L. | Combination therapy for inhalation administration |
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 |
US20230277451A1 (en) | 2020-10-09 | 2023-09-07 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
CN118475343A (zh) * | 2021-12-21 | 2024-08-09 | 凯西制药公司 | 填充在具有改善的耐湿性的吸入器中的干粉制剂 |
WO2023227781A1 (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 |
WO2023227782A1 (en) | 2022-05-27 | 2023-11-30 | Chiesi Farmaceutici S.P.A. | A pharmaceutical formulation for pressurised metered dose inhaler |
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GB0523653D0 (en) | 2005-11-21 | 2005-12-28 | Novartis Ag | Organic compounds |
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MY156950A (en) * | 2009-12-23 | 2016-04-15 | Chiesi Farma Spa | Aerosol formulation for copd |
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CN104582771B (zh) | 2012-08-29 | 2018-09-04 | 奇斯药制品公司 | 气溶胶吸入装置 |
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LT3096737T (lt) * | 2013-12-30 | 2018-06-11 | Chiesi Farmaceutici S.P.A. | Stabili glikopironio bromido ir formoterolio derinio suspausto aerozolio tirpalo kompozicija |
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