Tsis ntev los no, North China Pharmaceutical Co., Ltd. (tom ntej no hu ua "Lub Tuam Txhab"), los ntawm nws cov koom tes hauv North China Pharmaceutical Huasheng Co., Ltd.Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP)rau cov tshuaj nquag siv tshuaj muaj tshuaj (API) ntawm cyclosporine, muab los ntawm European Directorate rau Cov Tshuaj Zoo & Kev Noj Qab Haus Huv (EDQM). Peb tshaj tawm cov ntsiab lus tseem ceeb raws li hauv qab no:
I. Cov ntsiab lus tseem ceeb ntawm CEP Certificate rau Chemical API
| Tshuaj npe |
Ciclosporin |
| Dosage Form | Active Pharmaceutical Ingredients (API) |
| Daim ntawv pov thawj No. |
No. CEP2021-399-Rev 00 |
| Chaw Nyob Chaw Tsim Khoom | Tsis yog . 8 Yangzi Road, Shijiazhuang Economic & Technological Development Zone |
| Tso Cai | European Directorate rau Qhov Zoo ntawm Tshuaj & Kev Kho Mob (EDQM) |
| Hnub pom zoo | 20 Lub Ob Hlis 2024 |
II. Lwm Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Ciclosporin yog ib qho calcineurin inhibitor uas inhibits cov haujlwm ntawm T lymphocytes, yog li ua rau muaj kev tiv thaiv kab mob. Nws tau qhia txog kev tiv thaiv kev tsis lees paub tom qab kev hloov pauv allogeneic ntawm cov kabmob lossis cov ntaub so ntswg xws li lub raum, daim siab, lub plawv thiab cov pob txha, nrog rau kev tiv thaiv thiab kev kho mob ntawm graft- tiv thaiv -tus kab mob (GVHD) cuam tshuam nrog kev hloov pob txha pob txha. Nws yog feem ntau siv ua ke nrog lwm cov tshuaj tiv thaiv kab mob nrog rau cov tshuaj hormones adrenocortical los txhim kho kev ua tau zoo. Nyob rau hauv xyoo tas los no, muaj cov lus ceeb toom ntawm nws txoj kev tshawb fawb siv hauv kev kho mob ntawm uveitis, mob hnyav aplastic anemia, refractory immune thrombocytopenic purpura, psoriasis, thiab refractory lupus nephritis, thiab lwm yam.
