NO315260B1 - Höykonsentrert immunglobulinpreparat og fremgangsmåte for dets fremstilling - Google Patents
Höykonsentrert immunglobulinpreparat og fremgangsmåte for dets fremstilling Download PDFInfo
- Publication number
- NO315260B1 NO315260B1 NO19945045A NO945045A NO315260B1 NO 315260 B1 NO315260 B1 NO 315260B1 NO 19945045 A NO19945045 A NO 19945045A NO 945045 A NO945045 A NO 945045A NO 315260 B1 NO315260 B1 NO 315260B1
- Authority
- NO
- Norway
- Prior art keywords
- preparation
- immunoglobulin
- preparation according
- content
- osmolarity
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 61
- 108060003951 Immunoglobulin Proteins 0.000 title claims abstract description 46
- 102000018358 immunoglobulin Human genes 0.000 title claims abstract description 46
- 238000000034 method Methods 0.000 title claims description 7
- 150000001720 carbohydrates Chemical class 0.000 claims description 18
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 5
- 241000700605 Viruses Species 0.000 claims description 5
- 230000033228 biological regulation Effects 0.000 claims description 5
- 239000008103 glucose Substances 0.000 claims description 5
- 230000002779 inactivation Effects 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 4
- 229940072221 immunoglobulins Drugs 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 239000005720 sucrose Substances 0.000 claims description 4
- 239000008280 blood Substances 0.000 claims description 3
- 210000004369 blood Anatomy 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims description 3
- 239000012678 infectious agent Substances 0.000 claims description 2
- 230000006641 stabilisation Effects 0.000 claims description 2
- 238000011105 stabilization Methods 0.000 claims description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 10
- 239000000243 solution Substances 0.000 description 10
- 239000003381 stabilizer Substances 0.000 description 7
- 239000011780 sodium chloride Substances 0.000 description 5
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 4
- 230000003171 anti-complementary effect Effects 0.000 description 4
- 230000001105 regulatory effect Effects 0.000 description 4
- 239000007858 starting material Substances 0.000 description 4
- 238000004108 freeze drying Methods 0.000 description 3
- 238000001802 infusion Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 239000004471 Glycine Substances 0.000 description 2
- 206010020751 Hypersensitivity Diseases 0.000 description 2
- 230000002378 acidificating effect Effects 0.000 description 2
- 208000026935 allergic disease Diseases 0.000 description 2
- 230000007815 allergy Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 235000014633 carbohydrates Nutrition 0.000 description 2
- 238000011026 diafiltration Methods 0.000 description 2
- 239000012153 distilled water Substances 0.000 description 2
- -1 glucose and sucrose Chemical class 0.000 description 2
- 239000000644 isotonic solution Substances 0.000 description 2
- 238000011146 sterile filtration Methods 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 239000000539 dimer Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000013020 final formulation Substances 0.000 description 1
- 108010074605 gamma-Globulins Proteins 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 230000004957 immunoregulator effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
Classifications
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
- A61K47/26—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE4344824A DE4344824C1 (de) | 1993-12-28 | 1993-12-28 | Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO945045D0 NO945045D0 (no) | 1994-12-27 |
| NO945045L NO945045L (no) | 1995-06-29 |
| NO315260B1 true NO315260B1 (no) | 2003-08-11 |
Family
ID=6506449
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO19945045A NO315260B1 (no) | 1993-12-28 | 1994-12-27 | Höykonsentrert immunglobulinpreparat og fremgangsmåte for dets fremstilling |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US5608038A (da) |
| EP (1) | EP0661060B1 (da) |
| JP (1) | JP3040678B2 (da) |
| AT (2) | AT407707B (da) |
| CA (1) | CA2138853A1 (da) |
| CZ (1) | CZ284186B6 (da) |
| DE (2) | DE4344824C1 (da) |
| DK (1) | DK0661060T3 (da) |
| ES (1) | ES2158877T3 (da) |
| FI (1) | FI111224B (da) |
| HR (1) | HRP941018B1 (da) |
| HU (1) | HU220766B1 (da) |
| NO (1) | NO315260B1 (da) |
| RU (1) | RU2104713C1 (da) |
| YU (1) | YU77994A (da) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9283273B2 (en) | 1995-07-27 | 2016-03-15 | Genentech, Inc. | Protein formulation |
Families Citing this family (45)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ZA966075B (en) * | 1995-07-27 | 1998-01-19 | Genentech Inc | Protein formulation. |
| NZ500539A (en) * | 1995-07-27 | 2001-11-30 | Genentech Inc | An antibody that binds HER2 receptor in a composition for treating endometrial, lung, colon or bladder cancer |
| US6685940B2 (en) * | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| GB9610992D0 (en) | 1996-05-24 | 1996-07-31 | Glaxo Group Ltd | Concentrated antibody preparation |
| EP0852951A1 (de) * | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| IL133220A0 (en) * | 1997-06-13 | 2001-03-19 | Genentech Inc | Stabilized antibody formulation |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US6991790B1 (en) * | 1997-06-13 | 2006-01-31 | Genentech, Inc. | Antibody formulation |
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| IL155002A0 (en) | 2000-10-12 | 2003-10-31 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
| US7132100B2 (en) | 2002-06-14 | 2006-11-07 | Medimmune, Inc. | Stabilized liquid anti-RSV antibody formulations |
| US7425618B2 (en) * | 2002-06-14 | 2008-09-16 | Medimmune, Inc. | Stabilized anti-respiratory syncytial virus (RSV) antibody formulations |
| EP1551875A4 (en) * | 2002-06-21 | 2006-06-28 | Biogen Idec Inc | TAMPON PREPARATIONS FOR CONCENTRATING ANTIBODIES AND METHODS FOR USE THEREOF |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| MY150740A (en) * | 2002-10-24 | 2014-02-28 | Abbvie Biotechnology Ltd | Low dose methods for treating disorders in which tnf? activity is detrimental |
| US20060104968A1 (en) | 2003-03-05 | 2006-05-18 | Halozyme, Inc. | Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminogly ycanases |
| US20050158303A1 (en) * | 2003-04-04 | 2005-07-21 | Genentech, Inc. | Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations |
| DK1610820T4 (da) | 2003-04-04 | 2013-11-04 | Genentech Inc | Høj-koncentration antistof- og proteinformuleringer |
| EP1771476B1 (en) * | 2004-07-23 | 2014-12-10 | Genentech, Inc. | Crystallization of anti-vegf antibodies |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| SG162788A1 (en) | 2005-06-14 | 2010-07-29 | Amgen Inc | Self-buffering protein formulations |
| US20070190057A1 (en) | 2006-01-23 | 2007-08-16 | Jian Wu | Methods for modulating mannose content of recombinant proteins |
| AR059066A1 (es) | 2006-01-27 | 2008-03-12 | Amgen Inc | Combinaciones del inhibidor de la angiopoyetina -2 (ang2) y el inhibidor del factor de crecimiento endotelial vascular (vegf) |
| JP2010522752A (ja) | 2007-03-29 | 2010-07-08 | アボット・ラボラトリーズ | 結晶性抗ヒトｉｌ−１２抗体 |
| KR20150080038A (ko) * | 2007-11-30 | 2015-07-08 | 애브비 바이오테크놀로지 리미티드 | 단백질 제형 및 이의 제조방법 |
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| TWI532498B (zh) * | 2008-03-17 | 2016-05-11 | 巴克斯特保健公司 | 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法 |
| CN102301235B (zh) * | 2008-11-28 | 2014-11-19 | Abbvie公司 | 稳定的抗体组合物和用于稳定其的方法 |
| US20100158893A1 (en) * | 2008-12-19 | 2010-06-24 | Baxter International Inc. | Systems and methods for obtaining immunoglobulin from blood |
| TW201039854A (en) * | 2009-03-06 | 2010-11-16 | Genentech Inc | Antibody formulation |
| PL2477603T3 (pl) | 2009-09-17 | 2016-10-31 | Trwały preparat złożony hialuronidazy i immunoglobuliny oraz sposoby jego stosowania | |
| SI2542257T1 (en) | 2010-03-01 | 2018-01-31 | Bayer Healthcare Llc | Optimized monoclonal antibodies against Tissue Factor Pathway Inhibitor (TFPI) |
| FR2994390B1 (fr) | 2012-08-10 | 2014-08-15 | Adocia | Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| AU2013203043B2 (en) * | 2013-03-15 | 2016-10-06 | Takeda Pharmaceutical Company Limited | Methods to produce a human plasma-derived igg preparation enriched in brain disease-related natural iggs |
| IL312865B1 (en) | 2013-09-11 | 2025-02-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-reducing agents |
| US10568951B2 (en) | 2013-11-18 | 2020-02-25 | Formycon Ag | Pharmaceutical composition of an anti-VEGF antibody |
| US10478498B2 (en) | 2014-06-20 | 2019-11-19 | Reform Biologics, Llc | Excipient compounds for biopolymer formulations |
| US20160074515A1 (en) | 2014-06-20 | 2016-03-17 | Reform Biologics, Llc | Viscosity-reducing excipient compounds for protein formulations |
| US11357857B2 (en) | 2014-06-20 | 2022-06-14 | Comera Life Sciences, Inc. | Excipient compounds for protein processing |
| MX2017004306A (es) | 2014-10-01 | 2017-12-20 | Eagle Biologics Inc | Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad. |
| RU2599029C1 (ru) * | 2015-07-16 | 2016-10-10 | Игорь Геннадьевич Ковшик | Химерный иммуноглобулиновый препарат, обладающий специфическим противовирусным или антибактериальным действием |
| PT3334747T (pt) | 2015-08-13 | 2023-12-12 | Amgen Inc | Formulação de gonadotrofina líquida estável |
| MX2019004580A (es) | 2016-10-21 | 2019-08-12 | Amgen Inc | Formulaciones farmaceuticas y metodos para prepararlas. |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4075193A (en) * | 1976-11-26 | 1978-02-21 | Parke, Davis & Company | Process for producing intravenous immune globulin |
| AT359641B (de) * | 1978-09-19 | 1980-11-25 | Immuno Ag | Verfahren zur herstellung eines intravenoes ver- abreichbaren antikoerperhaeltigen immunglobulin- praeparates |
| US4186192A (en) * | 1978-12-18 | 1980-01-29 | Cutter Laboratories, Inc. | Stabilized immune serum globulin |
| JPS57203017A (en) * | 1981-06-09 | 1982-12-13 | Fujirebio Inc | Purifying method of immunoglobulin |
| US4499073A (en) * | 1981-08-24 | 1985-02-12 | Cutter Laboratories, Inc. | Intravenously injectable immune serum globulin |
| DK166763B1 (da) * | 1983-03-16 | 1993-07-12 | Immuno Ag | Immunoglobulin-g-holdig fraktion |
| EP0168506B2 (en) * | 1984-07-07 | 1998-01-07 | Armour Pharma GmbH | Process for preparing gamma globulin suitable for intravenous administration |
| JPH0825902B2 (ja) * | 1985-02-21 | 1996-03-13 | 株式会社ミドリ十字 | γ−グロブリンの加熱処理方法 |
| US5248767A (en) * | 1986-06-11 | 1993-09-28 | Behringwerke Aktiengesellschaft | Process for the preparation of a pasteurized immunoglobulin preparation using ethanol |
| DE3619565A1 (de) * | 1986-06-11 | 1987-12-17 | Behringwerke Ag | Verfahren zur herstellung einer pasteurisierten immunglobulinpraeparation |
| DE3825429C2 (de) * | 1988-07-27 | 1994-02-10 | Biotest Pharma Gmbh | Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt |
| CH684164A5 (de) * | 1992-01-10 | 1994-07-29 | Rotkreuzstiftung Zentrallab | Intravenös anwendbare Immunglobulinlösung. |
-
1993
- 1993-12-28 DE DE4344824A patent/DE4344824C1/de not_active Expired - Fee Related
-
1994
- 1994-12-20 US US08/359,901 patent/US5608038A/en not_active Expired - Fee Related
- 1994-12-21 AT AT0237894A patent/AT407707B/de not_active IP Right Cessation
- 1994-12-22 CZ CZ943284A patent/CZ284186B6/cs not_active IP Right Cessation
- 1994-12-22 CA CA002138853A patent/CA2138853A1/en not_active Abandoned
- 1994-12-23 ES ES94120595T patent/ES2158877T3/es not_active Expired - Lifetime
- 1994-12-23 AT AT94120595T patent/ATE201328T1/de not_active IP Right Cessation
- 1994-12-23 DE DE59409761T patent/DE59409761D1/de not_active Revoked
- 1994-12-23 DK DK94120595T patent/DK0661060T3/da active
- 1994-12-23 EP EP94120595A patent/EP0661060B1/de not_active Revoked
- 1994-12-27 RU RU94045287A patent/RU2104713C1/ru active
- 1994-12-27 JP JP6325623A patent/JP3040678B2/ja not_active Expired - Fee Related
- 1994-12-27 HU HU9403795A patent/HU220766B1/hu unknown
- 1994-12-27 NO NO19945045A patent/NO315260B1/no not_active IP Right Cessation
- 1994-12-27 HR HRP4344824.0A patent/HRP941018B1/xx not_active IP Right Cessation
- 1994-12-27 FI FI946104A patent/FI111224B/fi not_active IP Right Cessation
- 1994-12-28 YU YU77994A patent/YU77994A/sh unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9283273B2 (en) | 1995-07-27 | 2016-03-15 | Genentech, Inc. | Protein formulation |
Also Published As
| Publication number | Publication date |
|---|---|
| NO945045L (no) | 1995-06-29 |
| FI946104A (fi) | 1995-06-29 |
| EP0661060A2 (de) | 1995-07-05 |
| HU9403795D0 (en) | 1995-02-28 |
| EP0661060A3 (de) | 1997-01-15 |
| HRP941018B1 (en) | 1999-12-31 |
| HU220766B1 (hu) | 2002-05-28 |
| FI946104A0 (fi) | 1994-12-27 |
| CZ328494A3 (en) | 1995-07-12 |
| DK0661060T3 (da) | 2001-07-30 |
| FI111224B (fi) | 2003-06-30 |
| RU2104713C1 (ru) | 1998-02-20 |
| US5608038A (en) | 1997-03-04 |
| HRP941018A2 (en) | 1997-04-30 |
| ATA237894A (de) | 2000-10-15 |
| YU77994A (sh) | 1997-03-07 |
| AT407707B (de) | 2001-05-25 |
| JPH07206709A (ja) | 1995-08-08 |
| EP0661060B1 (de) | 2001-05-23 |
| NO945045D0 (no) | 1994-12-27 |
| DE4344824C1 (de) | 1995-08-31 |
| ATE201328T1 (de) | 2001-06-15 |
| JP3040678B2 (ja) | 2000-05-15 |
| CZ284186B6 (cs) | 1998-09-16 |
| HUT70449A (en) | 1995-10-30 |
| ES2158877T3 (es) | 2001-09-16 |
| CA2138853A1 (en) | 1995-06-29 |
| DE59409761D1 (de) | 2001-06-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |