BR112016026879A8 - composição farmacêutica aquosa, seu uso, e dispositivo de distribuição de fármaco - Google Patents

composição farmacêutica aquosa, seu uso, e dispositivo de distribuição de fármaco

Info

Publication number
BR112016026879A8
BR112016026879A8 BR112016026879A BR112016026879A BR112016026879A8 BR 112016026879 A8 BR112016026879 A8 BR 112016026879A8 BR 112016026879 A BR112016026879 A BR 112016026879A BR 112016026879 A BR112016026879 A BR 112016026879A BR 112016026879 A8 BR112016026879 A8 BR 112016026879A8
Authority
BR
Brazil
Prior art keywords
adalimumab
pharmaceutical composition
liquid pharmaceutical
delivery device
drug delivery
Prior art date
Application number
BR112016026879A
Other languages
English (en)
Other versions
BR112016026879A2 (pt
Inventor
Del Rio Alessandra
Rinaldi Gianluca
FRATARCANGELI Silvia
Original Assignee
Ares Trading Sa
Fresenius Kabi Deutschland Gmbh
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=50774704&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112016026879(A8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ares Trading Sa, Fresenius Kabi Deutschland Gmbh filed Critical Ares Trading Sa
Publication of BR112016026879A2 publication Critical patent/BR112016026879A2/pt
Publication of BR112016026879A8 publication Critical patent/BR112016026879A8/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Abstract

composição farmacêutica líquida. a presente invenção refere-se às novas composições farmacêuticas líquidas de adalimumab, as quais incluem adalimumab ou um biossimilar seu, um agente/sistema de tamponamento de acetato, tal como acetato de sódio/ácido acético, e um estabilizador de açúcar, tal como trealose. tal combinação de componentes fornece formulações tendo uma estabilidade (p.ex., na armazenagem, e quando expostas ao estresse) que é comparável com, ou um aperfeiçoamento sobre aquelas conhecidas na técnica, e com poucos ingredientes. tais avanços auxiliarão os tratamentos com o adalimumab a tornarem-se mais amplamente disponíveis, em custo menor, e prolongarão a viabilidade dos dispositivos de distribuição pré-carregados (p.ex., seringas pré-enchidas) para reduzir o desperdício desnecessário do fármaco.
BR112016026879A 2014-05-23 2015-05-15 composição farmacêutica aquosa, seu uso, e dispositivo de distribuição de fármaco BR112016026879A8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14169753.2A EP2946765B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
PCT/EP2015/060816 WO2015177057A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Publications (2)

Publication Number Publication Date
BR112016026879A2 BR112016026879A2 (pt) 2017-08-15
BR112016026879A8 true BR112016026879A8 (pt) 2021-06-29

Family

ID=50774704

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112016026879A BR112016026879A8 (pt) 2014-05-23 2015-05-15 composição farmacêutica aquosa, seu uso, e dispositivo de distribuição de fármaco
BR122021022508-7A BR122021022508B1 (pt) 2014-05-23 2015-05-15 Composição farmacêutica aquosa, seu uso, e dispositivo de distribuição de fármaco

Family Applications After (1)

Application Number Title Priority Date Filing Date
BR122021022508-7A BR122021022508B1 (pt) 2014-05-23 2015-05-15 Composição farmacêutica aquosa, seu uso, e dispositivo de distribuição de fármaco

Country Status (24)

Country Link
US (7) US10426832B2 (pt)
EP (4) EP3050557A1 (pt)
JP (1) JP6334819B2 (pt)
KR (4) KR20210108504A (pt)
CN (2) CN109248315B (pt)
AU (3) AU2015263340B2 (pt)
BR (2) BR112016026879A8 (pt)
CA (2) CA2946953C (pt)
CY (1) CY1120681T1 (pt)
DK (2) DK2946765T3 (pt)
ES (2) ES2600488T3 (pt)
HR (2) HRP20161311T1 (pt)
HU (2) HUE029849T2 (pt)
IL (3) IL249115B (pt)
LT (2) LT2946765T (pt)
MX (1) MX361061B (pt)
NZ (1) NZ725360A (pt)
PL (2) PL2946765T3 (pt)
PT (2) PT2946765T (pt)
RS (2) RS55548B1 (pt)
RU (2) RU2719431C2 (pt)
SG (3) SG10201806300VA (pt)
SI (2) SI2946765T1 (pt)
WO (1) WO2015177057A1 (pt)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2014337263B2 (en) 2013-10-16 2019-12-12 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
US10688187B2 (en) 2014-04-02 2020-06-23 Intas Pharmaceuticals Ltd. Liquid pharmaceutical composition of adalimumab
EP3050557A1 (en) * 2014-05-23 2016-08-03 Ares Trading S.A. Liquid pharmaceutical composition
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
WO2016118707A1 (en) 2015-01-21 2016-07-28 Oncobiologics, Inc. Modulation of charge variants in a monoclonal antibody composition
CN109563161A (zh) 2016-02-03 2019-04-02 安口生物公司 用于提高抗体稳定性的缓冲制剂
CR20180599A (es) * 2016-06-30 2019-04-09 Celltrion Inc Preparación farmacéutica líquida estable
US20200087390A1 (en) * 2016-12-21 2020-03-19 Amgen Inc. Anti-tnf alpha antibody formulations
EP3569224B1 (en) * 2017-01-11 2022-12-14 Celltrion Inc. Stable liquid formula
IT201700004019A1 (it) * 2017-01-16 2018-07-16 Gk Pharma Consultans Sa Composizione comprendente carnitina, colato di sodio, acetato di sodio ed eventualmente argento per uso nel trattamento di psoriasi, vitiligine e rosacea
UA123847C2 (uk) * 2017-03-16 2021-06-09 Лг Кем, Лтд. Рідка композиція анти-tnf альфа антитіла
EP3612217A4 (en) * 2017-04-18 2020-12-30 Dr. Reddy's Laboratories Limited STABLE LIQUID PHARMACEUTICAL COMPOSITION
AU2018336826B2 (en) * 2017-09-20 2022-01-27 Alvotech Hf Pharmaceutical formulations for adalimumab
CN110151988A (zh) * 2018-02-11 2019-08-23 百奥泰生物制药股份有限公司 一种靶向治疗TNF-α相关疾病的人抗体制剂
WO2020138517A1 (ko) * 2018-12-24 2020-07-02 삼성바이오에피스 주식회사 항-TNFα 항체를 포함하는 약제학적 조성물
WO2020145789A1 (ko) * 2019-01-11 2020-07-16 삼성바이오에피스 주식회사 항체를 포함하는 약학적 조성물, 이를 포함하는 디바이스, 및 이의 용도
TW202128220A (zh) * 2019-10-08 2021-08-01 韓商三星Ｂｉｏｅｐｉｓ股份有限公司 穩定液體組合物、其製備方法及含有其之調配物
CN117642180A (zh) * 2021-05-05 2024-03-01 I2O治疗公司 用于治疗炎性疾病和自身免疫性疾病的离子液体制剂

Family Cites Families (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6388197A (ja) 1986-09-30 1988-04-19 Tosoh Corp モノクロナル抗体の安定化方法
US6090382A (en) 1996-02-09 2000-07-18 Basf Aktiengesellschaft Human antibodies that bind human TNFα
TR199801532T2 (xx) 1996-02-09 1998-11-23 Basf Aktiengesellschaft �nsan TNFalfa 's�n� ba�layan insan antikorlar�.
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US5900404A (en) 1997-08-15 1999-05-04 Amgen Inc. Chemical modification of proteins to improve biocompatibility and bioactivity
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
KR101208291B1 (ko) 2003-04-04 2012-12-05 노파르티스 아게 고농도 항체 및 단백질 제형
WO2005072772A1 (en) 2004-01-30 2005-08-11 Suomen Punainen Risti Veripalvelu Pharmaceutical compositions
ZA200700947B (en) 2004-07-23 2008-06-25 Genentech Inc Crystallization of antibodies or fragments thereof
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
CA2600836A1 (en) 2005-03-08 2006-09-14 Pharmacia & Upjohn Company Llc Composition comprising an antibody against macrophage colony-stimulating factor (m-csf) and a chelating agent
CN105153306B (zh) 2005-06-07 2020-12-11 艾斯巴技术-诺华有限责任公司 抑制TNFα的稳定和可溶的抗体
KR20150080038A (ko) 2007-11-30 2015-07-08 애브비 바이오테크놀로지 리미티드 단백질 제형 및 이의 제조방법
US8080518B2 (en) 2007-12-05 2011-12-20 Arbor Vita Corporation Co-administration of an agent linked to an internalization peptide with an anti-inflammatory
CA2738243C (en) 2008-10-29 2020-09-29 Wyeth Llc Formulations of single domain antigen binding molecules
AU2009313756B2 (en) 2008-11-17 2015-02-26 F. Hoffmann-La Roche Ag Method and formulation for reducing aggregation of a macromolecule under physiological conditions
JP2012526121A (ja) * 2009-05-04 2012-10-25 アボツト・バイオテクノロジー・リミテツド ヒト抗ｔｎｆアルファ抗体の安定した高蛋白質濃度製剤
EP3708190A1 (en) 2010-02-26 2020-09-16 Novo Nordisk A/S Stable antibody containing compositions
CA2794929C (en) 2010-03-01 2018-06-05 Progenics Pharmaceuticals, Inc. Concentrated protein formulations and uses thereof
US20110223208A1 (en) 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
CA2792125C (en) 2010-03-22 2019-02-12 Genentech, Inc. Compositions and methods useful for stabilizing protein-containing formulations
EP2399604A1 (en) 2010-06-25 2011-12-28 F. Hoffmann-La Roche AG Novel antibody formulation
PT2637690T (pt) 2010-11-11 2016-12-27 Abbvie Biotechnology Ltd Formulações líquidas de anticorpo anti-tnf-alfa de concentração elevada
EP2471554A1 (en) * 2010-12-28 2012-07-04 Hexal AG Pharmaceutical formulation comprising a biopharmaceutical drug
EP2726090B1 (en) 2011-07-01 2020-01-01 Biogen MA Inc. Arginine - free tnfr : fc- fusion polypeptide compositions
GB201112429D0 (en) * 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
BR112014021325A2 (pt) * 2012-03-07 2017-08-22 Cadila Healthcare Ltd Formulação farmacêutica líquida e formulação liofilizada
EP2863951A1 (en) 2012-06-12 2015-04-29 Boehringer Ingelheim International GmbH Pharmaceutical formulation for a therapeutic antibody
ES2784861T3 (es) 2012-09-07 2020-10-01 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab
KR20150070384A (ko) 2012-10-25 2015-06-24 메디뮨 엘엘씨 안정한 저점도 항체 제제
EP2727602A1 (en) 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody
AR093297A1 (es) 2012-10-31 2015-05-27 Amgen Res (Munich) Gmbh Formulacion liquida que comprende un compuesto neutralizante de gm-csf
JP6339578B2 (ja) 2012-10-31 2018-06-06 タケダ・ゲー・エム・ベー・ハーＴａｋｅｄａ ＧｍｂＨ Ｇｍ−ｃｓｆ中和化合物を含む凍結乾燥製剤
AU2013337644A1 (en) 2012-11-01 2015-05-07 Abbvie Inc. Stable Dual Variable Domain Immunoglobulin protein formulations
CN104707146B (zh) 2013-12-16 2019-04-16 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
US10688187B2 (en) * 2014-04-02 2020-06-23 Intas Pharmaceuticals Ltd. Liquid pharmaceutical composition of adalimumab
EP3050557A1 (en) 2014-05-23 2016-08-03 Ares Trading S.A. Liquid pharmaceutical composition
ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
EP3569224B1 (en) 2017-01-11 2022-12-14 Celltrion Inc. Stable liquid formula

Also Published As

Publication number Publication date
LT2946765T (lt) 2016-11-25
EP3476386C0 (en) 2024-01-24
HRP20161311T1 (hr) 2016-12-02
RU2020112952A (ru) 2020-06-03
MX2016015304A (es) 2017-02-22
MX361061B (es) 2018-11-23
US20200016268A1 (en) 2020-01-16
PT3145487T (pt) 2018-10-19
KR20210108504A (ko) 2021-09-02
RU2016150640A3 (pt) 2018-12-07
US20210030871A1 (en) 2021-02-04
KR20230004960A (ko) 2023-01-06
RU2719431C2 (ru) 2020-04-17
US20210308262A1 (en) 2021-10-07
US20210322551A1 (en) 2021-10-21
KR20170005864A (ko) 2017-01-16
PT2946765T (pt) 2016-11-10
CN109248315A (zh) 2019-01-22
SI2946765T1 (sl) 2016-11-30
LT3145487T (lt) 2018-09-25
US20210121566A1 (en) 2021-04-29
SG10201806300VA (en) 2018-08-30
CY1120681T1 (el) 2019-12-11
IL263473A (en) 2019-01-31
KR20200017553A (ko) 2020-02-18
EP3145487B1 (en) 2018-08-22
CN109248315B (zh) 2021-11-09
RS57780B1 (sr) 2018-12-31
EP3476386A1 (en) 2019-05-01
IL263473B (en) 2021-05-31
SG10202000517YA (en) 2020-03-30
HUE029849T2 (en) 2017-04-28
US11707524B2 (en) 2023-07-25
JP2017516846A (ja) 2017-06-22
SG11201608745QA (en) 2016-11-29
SI3145487T1 (sl) 2018-10-30
EP3050557A1 (en) 2016-08-03
IL282481A (en) 2021-06-30
AU2020203119A1 (en) 2020-05-28
PL2946765T3 (pl) 2017-08-31
US10426832B2 (en) 2019-10-01
US10729769B2 (en) 2020-08-04
CN106456538A (zh) 2017-02-22
BR112016026879A2 (pt) 2017-08-15
RS55548B1 (sr) 2017-05-31
ES2600488T3 (es) 2017-02-09
DK2946765T3 (en) 2016-10-31
EP3145487A1 (en) 2017-03-29
NZ725360A (en) 2019-09-27
CA2946953C (en) 2021-05-18
EP2946765B1 (en) 2016-08-31
EP2946765A1 (en) 2015-11-25
ES2687600T3 (es) 2018-10-26
CA2946953A1 (en) 2015-11-26
IL249115A0 (en) 2017-01-31
AU2018220051B2 (en) 2020-06-04
AU2015263340A1 (en) 2016-11-03
DK3145487T3 (en) 2018-10-01
US11712471B2 (en) 2023-08-01
WO2015177057A1 (en) 2015-11-26
BR122021022508B1 (pt) 2023-04-11
AU2015263340B2 (en) 2018-08-09
EP3476386B1 (en) 2024-01-24
IL249115B (en) 2018-12-31
HRP20181479T1 (hr) 2018-11-02
HUE040237T2 (hu) 2019-02-28
CA3073703A1 (en) 2015-11-26
PL3145487T3 (pl) 2018-11-30
US20170196974A1 (en) 2017-07-13
JP6334819B2 (ja) 2018-05-30
KR102296766B1 (ko) 2021-09-03
US20210196824A1 (en) 2021-07-01
RU2016150640A (ru) 2018-06-26
AU2018220051A1 (en) 2018-09-06

Similar Documents

Publication Publication Date Title
BR112016026879A8 (pt) composição farmacêutica aquosa, seu uso, e dispositivo de distribuição de fármaco
EP4249060A3 (en) Liquid pharmaceutical composition of adalimumab
CY1124493T1 (el) Υγρη φαρμακευτικη συνθεση
BR112016013832A2 (pt) Uso de análogo e/ou derivado de insulina, formulação farmacêutica e processo para a preparação da mesma, kit e dispositivo médico
BR112016022159B8 (pt) Pó e método para melhorar a aplicação tópica de um agente de benefício ácido
BR112018001755A2 (pt) composições de insulina de ação rápida
BR112015031903A8 (pt) composto, sal farmaceuticamente aceitável, composição farmacêutica e uso de um composto
BR112015023922A2 (pt) composição farmacêutica compreendendo um ativador de ampk e um agente serotonérgico e métodos de uso destes
BR112016022607B8 (pt) Pó e método para aprimorar a aplicação tópica de minoxidil
BR112016002646A2 (pt) dispositivos e métodos de entrega de fármaco de múltiplas unidades
MY179818A (en) Antibody formulation
BR112014009131A8 (pt) formulações de etanercept estabilizadas com meglumina
JO3632B1 (ar) مستحضر قابل للحقن
BR112017004798A2 (pt) composição farmacêutica que contém um derivado de ácido hidroxâmico ou um seu sal
BR112018000067A2 (pt) dispositivo de liberação de uso único previamente preenchido com um agente reconstituível
BR112017002214A2 (pt) composto de fórmula (i), composição farmacêutica e usos de um composto
BR112016004358A8 (pt) combinação farmacêutica de um inibidor de alk e um inibidor de cdk para tratamento de doenças proliferativas de célula, composição farmacêutica, seus usos, e kit
PE20160534A1 (es) Sistema de administracion intrauterina
MX2017004772A (es) Composiciones y métodos para la administración fisiológica utilizando cannabidiol.
BR112018002520A2 (pt) Agonistas de tlr4 e composições dos mesmos e seuuso no tratamento de câncer
BR112018000039A2 (pt) dispositivo de liberação de uso único
MX2017008000A (es) Sistema de inyeccion de un solo uso.
BR112015014261A8 (pt) composto de danazol, seu uso e formulação farmacêutica compreendendo este
HRP20211308T1 (hr) Veterinarski postupak za izazivanje emeze
BR112018000018A2 (pt) dispositivo e sistema de liberação de uso único com aspectos de segurança

Legal Events

Date Code Title Description
B25A Requested transfer of rights approved

Owner name: FRESENIUS KABI DEUTSCHLAND GMBH (DE)

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B350 Update of information on the portal [chapter 15.35 patent gazette]
B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B11D Dismissal acc. art. 38, par 2 of ipl - failure to pay fee after grant in time