Eltrombopag

Kufotokozera Kwachidule:

Dzina la API Chizindikiro Woyambitsa Tsiku Lomaliza Ntchito (The US)
Eltrombopag ITP & Aplastic anemia Novartis & GSK Mayi. 20, 2023


Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

PRODUCT DETAIL

Eltrombopag ndi dzina lodziwika bwino la dzina lamalonda la mankhwala Promacta. Nthawi zina, akatswiri azachipatala atha kugwiritsa ntchito dzina lamalonda, Promacta, potchula dzina lamankhwala amtundu uliwonse, eltrombopag.

Mankhwalawa amagwiritsidwa ntchito pochiza mapulateleti otsika kwambiri mwa anthu omwe ali ndi vuto linalake la magazi lotchedwa chronic immune (idiopathic) thrombocytopenia purpura (ITP) kapena omwe ali ndi matenda a chiwindi a C. Angagwiritsidwenso ntchito pochiza anthu omwe ali ndi vuto linalake la magazi (aplastic). kuchepa magazi).

Eltrombopag imagwiritsidwa ntchito poletsa kutuluka kwa magazi kwa akulu ndi ana azaka 1 kapena kuposerapo, omwe ali ndi matenda osathaImmune thrombocytopenic purpura(ITP). ITP ndi vuto lotaya magazi chifukwa cha kusowa kwa mapulateleti m'magazi.

Eltrombopag sichiritso cha ITP ndipo sichingapangitse kuti mapulateleti anu akhale abwinobwino ngati muli ndi vutoli.

Eltrombopag imagwiritsidwanso ntchito poletsa magazi kwa akuluakulu omwe ali ndi matenda a chiwindi C omwe amachiritsidwa ndi interferon (monga Intron A, Infergen, Pegasys, PegIntron, Rebetron, Redipen, kapena Sylatron).

Eltrombopag imagwiritsidwanso ntchito limodzi ndi mankhwala ena pochiza kwambiriaplastic anemiamwa akulu ndi ana omwe ali ndi zaka zosachepera ziwiri.

Eltrombopag nthawi zina imaperekedwa pambuyo poti mankhwala ena alephera.

Eltrombopag si yogwiritsidwa ntchito pochiza matenda a myelodysplastic (omwe amatchedwanso "preleukemia").

Eltrombopag itha kugwiritsidwanso ntchito pazinthu zomwe sizinalembedwe mu bukhuli lamankhwala.

CERTIFICATE

2018 GMP-2
原料药GMP证书201811 (captopril,thalidomide etc)
GMP-of-PMDA-in-Chanyoo-平成28年08月03日 Nantong-Chanyoo-Pharmatech-Co
FDA-EIR-Letter-201901

KUSINTHA KWA KHALIDWE

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Malingaliro18Ma projekiti a Quality Consistency Evaluation omwe avomereza4,ndi6mapulojekiti akuvomerezedwa.

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Dongosolo lotsogola lapadziko lonse lapansi loyang'anira bwino layala maziko olimba pakugulitsa.

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Kuyang'anira kwabwino kumayendera nthawi yonse ya moyo wa chinthucho kuti zitsimikizire kuti zikuyenda bwino komanso zochiritsira.

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Gulu la Professional Regulatory Affairs limathandizira zofunikira pakufunsira ndikulembetsa.

MANAGEMENT ZOPHUNZITSA

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WOTHANDIZA

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