Nuwiq, Human cell line recombinant human factor VIII (Human-cl rhFVIII) 4000 IU powder and solvent for solution for injection. Vial of powder and prefilled WFI syringe

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

공공 평가 보고서 공공 평가 보고서 (PAR)
12-01-2021

유효 성분:

simoctocog alfa, Quantity: 4000 IU

제공처:

Octapharma Australia Pty Ltd

약제 형태:

Injection, powder for

구성:

Excipient Ingredients: poloxamer; arginine hydrochloride; sucrose; sodium chloride; sodium citrate dihydrate; calcium chloride dihydrate

관리 경로:

Intravenous

패키지 단위:

1 vial

처방전 유형:

exempt from scheduling - Appendix A; prescription medicine

치료 징후:

Treatment and prophylaxis of bleeding (also during and after surgery) in previously treated paediatric (>= 2 years) and adult patients with haemophilia A (congenital factor VIII deficiency). Nuwiq does not contain von Willebrand Factor and is thus not indicated to treat von Willebrand?s Disease.

제품 요약:

Visual Identification: Nuwiq - white to off-white lyophilised powder,WFI - clear, colourless liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Registered

승인 날짜:

2020-11-12