PL188222B1 - Wodny preparat farmaceutyczny zawierający ludzki hormon wzrostu oraz sposób jego wytwarzania - Google Patents
Wodny preparat farmaceutyczny zawierający ludzki hormon wzrostu oraz sposób jego wytwarzaniaInfo
- Publication number
- PL188222B1 PL188222B1 PL97329386A PL32938697A PL188222B1 PL 188222 B1 PL188222 B1 PL 188222B1 PL 97329386 A PL97329386 A PL 97329386A PL 32938697 A PL32938697 A PL 32938697A PL 188222 B1 PL188222 B1 PL 188222B1
- Authority
- PL
- Poland
- Prior art keywords
- growth hormone
- amino acid
- amount
- hgh
- histidine
- Prior art date
Links
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Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK49096 | 1996-04-24 | ||
| PCT/DK1997/000184 WO1997039768A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation containing growth hormone, an amino acid and a non-ionic detergent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| PL329386A1 PL329386A1 (en) | 1999-03-29 |
| PL188222B1 true PL188222B1 (pl) | 2004-12-31 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL97329386A PL188222B1 (pl) | 1996-04-24 | 1997-04-24 | Wodny preparat farmaceutyczny zawierający ludzki hormon wzrostu oraz sposób jego wytwarzania |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US20020077461A1 (OSRAM) |
| EP (2) | EP0904099B1 (OSRAM) |
| JP (2) | JP4176834B2 (OSRAM) |
| KR (1) | KR20000010630A (OSRAM) |
| CN (1) | CN1130223C (OSRAM) |
| AT (1) | ATE309819T1 (OSRAM) |
| AU (1) | AU733592B2 (OSRAM) |
| BR (1) | BR9708858A (OSRAM) |
| CA (1) | CA2252535C (OSRAM) |
| CZ (1) | CZ298292B6 (OSRAM) |
| DE (1) | DE69734653T2 (OSRAM) |
| DK (1) | DK0904099T3 (OSRAM) |
| ES (1) | ES2253774T3 (OSRAM) |
| HU (1) | HU229868B1 (OSRAM) |
| IL (2) | IL126463A0 (OSRAM) |
| NO (1) | NO323360B1 (OSRAM) |
| PL (1) | PL188222B1 (OSRAM) |
| RU (1) | RU2236250C2 (OSRAM) |
| UA (1) | UA66758C2 (OSRAM) |
| WO (1) | WO1997039768A1 (OSRAM) |
Families Citing this family (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5981485A (en) | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| NZ332762A (en) | 1996-07-24 | 2000-09-29 | Warner Lambert Co | Isobutylgaba and its derivatives for the treatment of pain |
| WO1999024071A1 (en) * | 1997-11-12 | 1999-05-20 | Alza Corporation | Method for decreasing self-association of polypeptides |
| GB9803448D0 (en) * | 1998-02-18 | 1998-04-15 | Pharma Mar Sa | Pharmaceutical formulation |
| JP4711520B2 (ja) * | 2000-03-21 | 2011-06-29 | 日本ケミカルリサーチ株式会社 | 生理活性ペプチド含有粉末 |
| AU8111301A (en) | 2000-08-07 | 2002-02-18 | Inhale Therapeutic Syst | Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation |
| EP1603588A2 (en) * | 2003-03-18 | 2005-12-14 | Ares Trading S.A. | Stabilisation of growth hormones in solution |
| CN106215226A (zh) | 2003-03-24 | 2016-12-14 | 健赞公司 | 利用逆向热敏聚合物的暂时栓塞 |
| DE10333317A1 (de) | 2003-07-22 | 2005-02-17 | Biotecon Therapeutics Gmbh | Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA) |
| WO2005046438A2 (en) * | 2003-11-06 | 2005-05-26 | Pluromed, Inc. | Internal clamp for surgical procedures |
| BRPI0418115A (pt) * | 2003-12-23 | 2007-04-17 | Pharmacia Corp | formulação lìquida estável de hormÈnio de crescimento |
| KR101120879B1 (ko) * | 2004-04-07 | 2012-02-27 | 아레스 트레이딩 에스.아. | 액체 성장 호르몬 제제 |
| CA2594561C (en) * | 2004-12-22 | 2014-12-23 | Ambrx, Inc. | Formulations of human growth hormone comprising a non-naturally encoded amino acid |
| JP2008525473A (ja) * | 2004-12-22 | 2008-07-17 | アンブレツクス・インコーポレイテツド | 修飾されたヒト成長ホルモン |
| ZA200704928B (en) * | 2004-12-22 | 2009-04-29 | Ambrx Inc | Formulations of human growth hormone comprising a non-naturally encoded amino acid |
| JP2009506096A (ja) | 2005-08-30 | 2009-02-12 | ノボ ノルディスク ヘルス ケア アーゲー | ペグ化成長ホルモンの液状調製物 |
| WO2007033427A1 (en) * | 2005-09-23 | 2007-03-29 | Metabolic Pharmaceuticals Limited | Stabilisation of peptides with basic amino acids |
| CN1939534B (zh) * | 2005-09-27 | 2010-12-01 | 长春金赛药业股份有限公司 | 含有人生长激素或人粒细胞巨噬细胞刺激因子的用于治疗损伤和溃疡的外用制剂 |
| CN101505789A (zh) | 2006-07-06 | 2009-08-12 | 株式会社大熊 | 稳定的人生长激素液体制剂 |
| CN101495155A (zh) | 2006-07-07 | 2009-07-29 | 诺沃-诺迪斯克保健股份有限公司 | 新的蛋白结合物及其制备方法 |
| AU2007333959A1 (en) * | 2006-12-18 | 2008-06-26 | Altus Pharmaceuticals Inc. | Human growth hormone formulations |
| CN103002918B (zh) | 2010-01-22 | 2016-05-04 | 诺沃—诺迪斯克保健股份有限公司 | 体内功效延长的生长激素 |
| RU2012134974A (ru) | 2010-01-22 | 2014-02-27 | Ново Нордиск Хелс Кеа Аг | Стабилизированное соединение гормона роста |
| KR101337797B1 (ko) * | 2010-07-14 | 2013-12-06 | 한미사이언스 주식회사 | 지속형 인간 성장 호르몬 결합체 액상 제제 |
| RU2592671C2 (ru) * | 2010-09-21 | 2016-07-27 | Ферринг Б.В. | Улучшенный способ получения рекомбинантного человеческого гормона роста |
| US9216219B2 (en) | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
| EP2872161B1 (en) | 2012-06-26 | 2020-12-16 | Del Mar Pharmaceuticals | Dianhydrogalactitol for use in treating tyrosine-kinase-inhibitor-resistant malignancies in patients with genetic polymorphisms or ahi1 dysregulations or mutations |
| CN105120887A (zh) | 2013-04-05 | 2015-12-02 | 诺和诺德保健股份有限公司 | 生长激素化合物制剂 |
| AU2014251038A1 (en) | 2013-04-08 | 2015-11-26 | Dennis M. Brown | Therapeutic benefit of suboptimally administered chemical compounds |
| US9993460B2 (en) | 2013-07-26 | 2018-06-12 | Race Oncology Ltd. | Compositions to improve the therapeutic benefit of bisantrene and analogs and derivatives thereof |
| MX2016003705A (es) * | 2013-09-27 | 2016-05-16 | Hanmi Pharm Ind Co Ltd | Formulacion de un conjugado de hormona del crecimiento humana de accion prolongada. |
| US9119832B2 (en) | 2014-02-05 | 2015-09-01 | The Regents Of The University Of California | Methods of treating mild brain injury |
| WO2017075535A1 (en) | 2015-10-28 | 2017-05-04 | Oxeia Biopharmaceuticals, Inc. | Methods of treating neurodegenerative conditions |
| HUE064656T2 (hu) | 2016-03-28 | 2024-04-28 | Incyte Corp | Pirrolotriazin vegyületek mint TAM inhibitorok |
| WO2019049967A1 (ja) | 2017-09-07 | 2019-03-14 | Ｊｃｒファーマ株式会社 | 水性医薬組成物 |
| SMT202200011T1 (it) | 2017-09-27 | 2022-03-21 | Incyte Corp | Sali di derivati di pirrolotriazina utili come inibitori di tam |
| KR102839002B1 (ko) | 2018-06-29 | 2025-07-29 | 인사이트 코포레이션 | Axl/mer 억제제의 제형 |
| PH12022552347A1 (en) | 2020-03-06 | 2024-01-29 | Incyte Corp | Combination therapy comprising axl/mer and pd-1/pd-l1 inhibitors |
| CN115634284B (zh) * | 2022-10-31 | 2025-02-11 | 景泽生物医药(合肥)股份有限公司 | 一种促性腺激素冻干制剂及其制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| DK204791D0 (da) * | 1991-12-20 | 1991-12-20 | Novo Nordisk As | Hidtil ukendt farmaceutisk praeparat |
| RO111990B1 (ro) * | 1991-12-20 | 1997-04-30 | Novo Nordisk As | Preparate farmaceutice, continand un hormon de crestere sau un derivat al acestuia, si procedeu de preparare |
| IL106524A (en) * | 1992-07-31 | 2000-08-31 | Genentech Inc | Human growth hormone aqueous formulation |
-
1997
- 1997-04-23 US US08/842,293 patent/US20020077461A1/en not_active Abandoned
- 1997-04-24 CN CN97194040A patent/CN1130223C/zh not_active Expired - Lifetime
- 1997-04-24 ES ES97918073T patent/ES2253774T3/es not_active Expired - Lifetime
- 1997-04-24 AU AU26343/97A patent/AU733592B2/en not_active Expired
- 1997-04-24 IL IL12646397A patent/IL126463A0/xx active IP Right Grant
- 1997-04-24 HU HU9902476A patent/HU229868B1/hu unknown
- 1997-04-24 BR BR9708858A patent/BR9708858A/pt not_active Application Discontinuation
- 1997-04-24 DE DE69734653T patent/DE69734653T2/de not_active Expired - Lifetime
- 1997-04-24 KR KR1019980708535A patent/KR20000010630A/ko not_active Ceased
- 1997-04-24 EP EP97918073A patent/EP0904099B1/en not_active Expired - Lifetime
- 1997-04-24 CA CA002252535A patent/CA2252535C/en not_active Expired - Lifetime
- 1997-04-24 WO PCT/DK1997/000184 patent/WO1997039768A1/en not_active Ceased
- 1997-04-24 AT AT97918073T patent/ATE309819T1/de active
- 1997-04-24 EP EP05110701A patent/EP1629832A1/en not_active Withdrawn
- 1997-04-24 RU RU98121135/15A patent/RU2236250C2/ru active
- 1997-04-24 PL PL97329386A patent/PL188222B1/pl unknown
- 1997-04-24 DK DK97918073T patent/DK0904099T3/da active
- 1997-04-24 JP JP53762297A patent/JP4176834B2/ja not_active Expired - Lifetime
- 1997-04-24 CZ CZ0320798A patent/CZ298292B6/cs not_active IP Right Cessation
- 1997-04-24 UA UA98105593A patent/UA66758C2/xx unknown
-
1998
- 1998-10-04 IL IL126463A patent/IL126463A/en not_active IP Right Cessation
- 1998-10-23 NO NO19984951A patent/NO323360B1/no not_active IP Right Cessation
-
2008
- 2008-06-03 JP JP2008145780A patent/JP2008231124A/ja not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| EP0904099B1 (en) | 2005-11-16 |
| AU733592B2 (en) | 2001-05-17 |
| PL329386A1 (en) | 1999-03-29 |
| NO984951L (no) | 1998-10-23 |
| EP1629832A1 (en) | 2006-03-01 |
| ATE309819T1 (de) | 2005-12-15 |
| CZ298292B6 (cs) | 2007-08-15 |
| CA2252535C (en) | 2009-06-23 |
| KR20000010630A (ko) | 2000-02-25 |
| UA66758C2 (en) | 2004-06-15 |
| JP2008231124A (ja) | 2008-10-02 |
| WO1997039768A1 (en) | 1997-10-30 |
| HUP9902476A3 (en) | 2000-12-28 |
| JP2000508665A (ja) | 2000-07-11 |
| RU2236250C2 (ru) | 2004-09-20 |
| CN1216472A (zh) | 1999-05-12 |
| US20020077461A1 (en) | 2002-06-20 |
| CZ320798A3 (cs) | 1999-03-17 |
| IL126463A (en) | 2007-06-17 |
| DK0904099T3 (da) | 2006-03-06 |
| EP0904099A1 (en) | 1999-03-31 |
| HUP9902476A2 (hu) | 2000-11-28 |
| CA2252535A1 (en) | 1997-10-30 |
| NO984951D0 (no) | 1998-10-23 |
| IL126463A0 (en) | 1999-08-17 |
| ES2253774T3 (es) | 2006-06-01 |
| BR9708858A (pt) | 1999-08-03 |
| CN1130223C (zh) | 2003-12-10 |
| AU2634397A (en) | 1997-11-12 |
| DE69734653D1 (de) | 2005-12-22 |
| DE69734653T2 (de) | 2006-08-10 |
| NO323360B1 (no) | 2007-04-10 |
| HU229868B1 (en) | 2014-10-28 |
| JP4176834B2 (ja) | 2008-11-05 |
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