CHMP會議重點內容(2020年12月)

 

此次的人類用醫藥品委員會(CHMP)，共有15項新藥品項獲得核准推薦

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-7-10-december-2020

商品名	學名	適應症	附註
Heplisav B	hepatitis B surface antigen	active immunisation against hepatitis B virus infection
Rukobia	fostemsavir	multidrug resistant HIV-1 infection.
Tukysa	tucatinib	HER2-positive locally advanced or metastatic breast cancer.
Enhertu	trastuzumab deruxtecan	metastatic HER2-positive breast cancer	conditional marketing authorisation accelerated assessment
Retsevmo	selpercatinib	RET-fusion positive non-small cell lung cancer, RET-fusion positive thyroid cancer RET-mutant medullary-thyroid cancer.	conditional marketing authorisation
Sibnayal	potassium citrate / potassium hydrogen carbonate	distal renal tubular acidosis	orphan medicine
Inrebic	fedratinib	primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia	orphan medicine
Lumoxiti	moxetumomab pasudotox	relapsed or refractory hairy cell leukaemia	exceptional circumstances orphan medicine
Kixelle	insulin aspart	diabetes mellitus	biosimilar medicines
Yuflyma	adalimumab	certain inflammatory and autoimmune disorders	biosimilar medicines
Lenalidomide Krka	lenalidomide	multiple myeloma and follicular lymphoma	generic medicines
Lenalidomide Krka d.d.	lenalidomide	multiple myeloma, myelodysplastic syndromes, and follicular lymphoma	generic medicines
Lenalidomide Krka d.d. Novo mesto	lenalidomide	multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma	generic medicines
Sunitinib Accord	sunitinib	cancer	generic medicines
Ogluo	glucagon	severe hypoglycaemia in diabetes mellitus	hybrid medicine(混合藥品)