MX2019003340A - Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion prenasal. - Google Patents
Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion prenasal.Info
- Publication number
- MX2019003340A MX2019003340A MX2019003340A MX2019003340A MX2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A
- Authority
- MX
- Mexico
- Prior art keywords
- testosterone
- low
- present
- gels
- sexual
- Prior art date
Links
- MUMGGOZAMZWBJJ-DYKIIFRCSA-N Testostosterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 MUMGGOZAMZWBJJ-DYKIIFRCSA-N 0.000 title abstract 28
- 229960003604 testosterone Drugs 0.000 title abstract 14
- 239000000499 gel Substances 0.000 title abstract 7
- 238000013270 controlled release Methods 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 230000036765 blood level Effects 0.000 abstract 4
- 230000001568 sexual effect Effects 0.000 abstract 4
- 206010002261 Androgen deficiency Diseases 0.000 abstract 1
- 206010002652 Anorgasmia Diseases 0.000 abstract 1
- 206010057671 Female sexual dysfunction Diseases 0.000 abstract 1
- 206010058359 Hypogonadism Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 208000035475 disorder Diseases 0.000 abstract 1
- 230000035558 fertility Effects 0.000 abstract 1
- 208000017020 hypoactive sexual desire disease Diseases 0.000 abstract 1
- 230000001939 inductive effect Effects 0.000 abstract 1
- 210000002741 palatine tonsil Anatomy 0.000 abstract 1
- 230000009257 reactivity Effects 0.000 abstract 1
- 230000001020 rhythmical effect Effects 0.000 abstract 1
- 210000002966 serum Anatomy 0.000 abstract 1
- 230000021595 spermatogenesis Effects 0.000 abstract 1
- 230000000638 stimulation Effects 0.000 abstract 1
- 230000000153 supplemental effect Effects 0.000 abstract 1
- 230000001839 systemic circulation Effects 0.000 abstract 1
- 238000002560 therapeutic procedure Methods 0.000 abstract 1
Classifications
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K9/0043—Nose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
-
- 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
- A61P25/24—Antidepressants
-
- 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
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
-
- 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
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/26—Androgens
-
- 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
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Inorganic Chemistry (AREA)
- Diabetes (AREA)
- Gynecology & Obstetrics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Otolaryngology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biomedical Technology (AREA)
- Pregnancy & Childbirth (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La presente invención se refiere a geles de testosterona intranasal para la liberación controlada de testosterona en la circulación sistémica de hombres y mujeres para proveer niveles sanguíneos efectivos constantes de testosterona, sin inducir picos repentinos indeseados de testosterona en los niveles sanguíneos, después de la administración pernasal. Los geles de testosterona intranasal de la presente invención son seguros, convenientes para usar, bien tolerados, estables y de elaboración fácil y reproducible a gran escala. Además, como se cree que el nivel sanguíneo supra-normal y sub-normal de testosterona se mantiene esencialmente en un mínimo o se evitan y los niveles séricos de testosterona se mantienen esencialmente constantes durante la vida útil de la dosis, es decir, los geles de testosterona intranasal de la presente invención reproducen o restauran los niveles sanguíneos de testosterona a los niveles de testosterona rítmicos diarios fisiológicos normales, los nuevos geles de testosterona intranasal de la presente invención son especialmente adecuados para la terapia suplementaria o de reemplazo de testosterona y efectivos para el tratamiento de hombres en los que se diagnosticó, por ejemplo, deficiencia de testosterona en el hombre, tal como, baja libido sexual, bajo impulso sexual, baja actividad sexual, baja fertilidad, baja espermatogénesis, aspermatogénesis, depresión y/o hipogonadismo, y mujeres en las que se diagnosticó, por ejemplo, disfunción sexual femenina, tal como, baja libido sexual, bajo impulso sexual, baja actividad sexual, baja reactividad de las amígdalas, baja estimulación sexual, enfermedad del deseo sexual hipoactivo (''HSDD"), trastorno del impulso sexual femenino y/o anorgasmia. La presente invención también se refiere a métodos y a sistemas de aplicadores sin aire, de múltiples dosis, prellenados para la administración pernasal del gel de testosterona nasal de la presente invención.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161486324P | 2011-05-15 | 2011-05-15 | |
| US201161486634P | 2011-05-16 | 2011-05-16 | |
| PCT/IB2012/001127 WO2012156822A1 (en) | 2011-05-15 | 2012-05-15 | Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2019003340A true MX2019003340A (es) | 2019-07-04 |
| MX374398B MX374398B (es) | 2025-03-06 |
Family
ID=46579248
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019003340A MX374398B (es) | 2011-05-15 | 2012-05-15 | Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal. |
| MX2013013369A MX2013013369A (es) | 2011-05-15 | 2012-05-15 | Formulaciones de gel bioadhesivo de testosterona intranasal y uso del mismo para tratar hipogonadismo masculino. |
| MX2020008599A MX395212B (es) | 2011-05-15 | 2012-05-15 | Geles nasales de liberación controlada de testosterona, métodos y sistemas aplicadores multidosis pre cargados para administración pernasal. |
| MX2013013388A MX363561B (es) | 2011-05-15 | 2012-05-15 | Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal. |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2013013369A MX2013013369A (es) | 2011-05-15 | 2012-05-15 | Formulaciones de gel bioadhesivo de testosterona intranasal y uso del mismo para tratar hipogonadismo masculino. |
| MX2020008599A MX395212B (es) | 2011-05-15 | 2012-05-15 | Geles nasales de liberación controlada de testosterona, métodos y sistemas aplicadores multidosis pre cargados para administración pernasal. |
| MX2013013388A MX363561B (es) | 2011-05-15 | 2012-05-15 | Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal. |
Country Status (16)
| Country | Link |
|---|---|
| EP (3) | EP3977982A1 (es) |
| JP (9) | JP6152092B2 (es) |
| KR (10) | KR20140045400A (es) |
| CN (4) | CN109481394B (es) |
| AR (2) | AR086409A1 (es) |
| AU (11) | AU2012257492A1 (es) |
| BR (2) | BR112013029336B1 (es) |
| CA (3) | CA2836398C (es) |
| DK (1) | DK2714006T3 (es) |
| EA (1) | EA201391701A1 (es) |
| ES (1) | ES2859784T3 (es) |
| IL (2) | IL229401A0 (es) |
| MX (4) | MX374398B (es) |
| PL (1) | PL2714006T4 (es) |
| WO (2) | WO2012156822A1 (es) |
| ZA (2) | ZA201309264B (es) |
Families Citing this family (49)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR086400A1 (es) | 2011-05-13 | 2013-12-11 | Trimel Pharmaceuticals Corp | Formulaciones en gel intranasal de testosterona en dosis de menor potencia y uso de las mismas para el tratamiento de la anorgasmia o el trastorno de deseo sexual hipoactivo |
| US9757388B2 (en) | 2011-05-13 | 2017-09-12 | Acerus Pharmaceuticals Srl | Intranasal methods of treating women for anorgasmia with 0.6% and 0.72% testosterone gels |
| US20130045958A1 (en) | 2011-05-13 | 2013-02-21 | Trimel Pharmaceuticals Corporation | Intranasal 0.15% and 0.24% testosterone gel formulations and use thereof for treating anorgasmia or hypoactive sexual desire disorder |
| JP6152092B2 (ja) * | 2011-05-15 | 2017-06-28 | エーセラス ファーマシューティカルズ コーポレーション | 経鼻投与のための徐放テストステロン鼻腔内ゲル、方法および複数回用量プレフィルアプリケーターシステム |
| US8971800B2 (en) * | 2011-05-31 | 2015-03-03 | Qualcomm Incorporated | Methods and apparatus for improving NFC activation and data exchange reporting mechanisms |
| US9301920B2 (en) | 2012-06-18 | 2016-04-05 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| RS62297B1 (sr) | 2011-11-23 | 2021-09-30 | Therapeuticsmd Inc | Prirodne kombinovane hormonske supstitucione formulacije i terapije |
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| US11246875B2 (en) | 2012-12-21 | 2022-02-15 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10537581B2 (en) | 2012-12-21 | 2020-01-21 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10568891B2 (en) | 2012-12-21 | 2020-02-25 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10471072B2 (en) | 2012-12-21 | 2019-11-12 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
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| US11744838B2 (en) | 2013-03-15 | 2023-09-05 | Acerus Biopharma Inc. | Methods of treating hypogonadism with transnasal testosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event |
| EP4382165A3 (en) * | 2013-10-07 | 2024-08-21 | Antares Pharma, Inc. | Hematocrit modulation through needle assisted jet injection of testosterone |
| EP4062918A1 (en) * | 2014-02-19 | 2022-09-28 | Antares Pharma, Inc. | Needle assisted jet injection administration of testosterone compositions |
| JP2017516768A (ja) | 2014-05-22 | 2017-06-22 | セラピューティックスエムディー インコーポレーテッドＴｈｅｒａｐｅｕｔｉｃｓｍｄ， Ｉｎｃ． | 天然の併用ホルモン補充療法剤及び療法 |
| US10098894B2 (en) | 2014-07-29 | 2018-10-16 | Therapeuticsmd, Inc. | Transdermal cream |
| WO2016123317A1 (en) * | 2015-01-28 | 2016-08-04 | Prometheon Pharma, Llc | Topical formulations of growth factors |
| EP4233873A3 (en) * | 2015-06-29 | 2023-10-18 | Lyra Therapeutics, Inc. | Implantable scaffolds for treatment of sinusitis |
| US10328087B2 (en) | 2015-07-23 | 2019-06-25 | Therapeuticsmd, Inc. | Formulations for solubilizing hormones |
| BR102015020878B1 (pt) * | 2015-08-28 | 2019-08-27 | F B M Ind Farmaceutica Ltda | formulação farmacêutica nasal de testosterona e “kit” em forma de cartela de dispositivos nasais unitários para aplicação de monodose de testosterona. |
| AU2017206048B2 (en) * | 2016-01-07 | 2023-04-13 | Viramal Limited | Gel compositions for transdermal delivery to maximize drug concentrations in the stratum corneum and serum and methods of use thereof |
| US10286077B2 (en) | 2016-04-01 | 2019-05-14 | Therapeuticsmd, Inc. | Steroid hormone compositions in medium chain oils |
| US9931349B2 (en) | 2016-04-01 | 2018-04-03 | Therapeuticsmd, Inc. | Steroid hormone pharmaceutical composition |
| CA3021989A1 (en) | 2016-04-25 | 2017-11-02 | Marc Andrew Koska | Medical delivery system |
| CA3026274A1 (en) * | 2016-06-02 | 2017-12-07 | Acerus Pharmaceutical Corporation | Nasal cannabidiol compositions |
| KR102387241B1 (ko) * | 2016-06-03 | 2022-04-15 | 엠 이티 피 파마 아게 | 다공성 부형제를 갖는 비강용 약제학적 조성물 |
| CA3050361A1 (en) | 2017-01-20 | 2018-07-26 | M et P Pharma AG | Nasal pharmaceutical compositions for reducing the risks of exposure to air pollutants |
| WO2018231028A1 (ko) * | 2017-06-17 | 2018-12-20 | 엘지전자(주) | 무선 통신 시스템에서 단말의 등록 방법 및 이를 위한 장치 |
| WO2019099954A1 (en) | 2017-11-17 | 2019-05-23 | Koska Family Limited | Systems and methods for fluid delivery manifolds |
| CN111386119A (zh) * | 2017-11-27 | 2020-07-07 | Aska制药株式会社 | 粉末鼻腔给药制剂 |
| MX2020008147A (es) | 2018-02-02 | 2020-10-28 | Acerus Biopharma Inc | Metodos de terapia de testosterona. |
| WO2019175290A1 (en) | 2018-03-13 | 2019-09-19 | Beckley Canopy Therapeutics Limited | Cannabis or cannabis derived compositions for promoting cessation of chemical dependence |
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| EP3659583B1 (en) | 2018-11-30 | 2023-06-07 | Viramal Limited | A method of preparing a gelling agent, the gelling agent obtained thereby, and the use of said gelling agent |
| US20200170962A1 (en) | 2018-11-30 | 2020-06-04 | F. Markus Leweke | Nasal cannabidiol compositions |
| SG11202106306YA (en) * | 2018-12-14 | 2021-07-29 | Acerus Biopharma Inc | Active ester derivatives of testosterone, compositions and uses thereof |
| USD1052082S1 (en) | 2020-06-01 | 2024-11-19 | Koska Family Limited | Sealed fluid container |
| CN112121049B (zh) * | 2020-08-28 | 2022-02-01 | 嘉兴市第一医院 | 顺式阿曲库铵在制备治疗男性性腺功能减退症的药物中的应用 |
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| GB202307501D0 (en) * | 2023-05-19 | 2023-07-05 | Lawley Pharmaceuticals Pty Ltd | Process for preparing dispensable testosterone cream |
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| EP1790343A1 (en) * | 2005-11-11 | 2007-05-30 | Emotional Brain B.V. | Pharmaceuticals formulations and uses thereof in the treatment of female sexual dysfunction |
| CN101099742A (zh) * | 2006-07-06 | 2008-01-09 | 上海富海科申药业有限公司 | 能够减少皮肤刺激的睾酮凝胶制剂 |
| RU2480208C2 (ru) * | 2006-10-04 | 2013-04-27 | М Унд П Патент Акциенгезелльшафт | Система доставки с контролируемым высвобождением для назального применения нейротрансмиттеров |
| AU2008231781B2 (en) * | 2007-03-23 | 2012-09-20 | Besins Healthcare Luxembourg Sarl | Compositions and method for treating pediatric hypogonadism |
| EP2191833B1 (en) * | 2007-09-20 | 2013-02-13 | Shiseido Company, Ltd. | Transdermally absorbable preparation |
| EP2060300B1 (en) * | 2007-11-13 | 2015-04-15 | Curadis GmbH | C-19 steroids for therapeutic uses |
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