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Atypical hemolytic uremic syndrome (aHUS): 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

Atypical hemolytic uremic syndrome (aHUS) clinical trial

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

United States

  • eculizumab (Soliris); ravulizumab-cwvz (Ultomiris)[1]FDA-approvedcomplement-mediated thrombotic microangiopathy; STEC-HUS exclusion caveat; Complement C5 inhibition for aHUS / complement-mediated TMA; Ultomiris label specifies adult and pediatric patients 1 month and older. · U.S. labels do not establish individual eligibility or sequencing. Complement inhibitor therapy includes meningococcal infection risk management, vaccination/prophylaxis considerations, and REMS. STEC-HUS is outside the labeled aHUS use. Confidence/conflicts: High for U.S. regulatory status and STEC-HUS limitation; no conflict identified.
  • eculizumab (Soliris); ravulizumab-cwvz (Ultomiris)[1]FDA-approvedcomplement-mediated thrombotic microangiopathy; STEC-HUS exclusion caveat; Complement C5 inhibition for aHUS / complement-mediated TMA; Ultomiris label specifies adult and pediatric patients 1 month and older. · U.S. labels do not establish individual eligibility or sequencing. Complement inhibitor therapy includes meningococcal infection risk management, vaccination/prophylaxis considerations, and REMS. STEC-HUS is outside the labeled aHUS use. Confidence/conflicts: High for U.S. regulatory status and STEC-HUS limitation; no conflict identified.

European Union

  • eculizumab (Soliris); ravulizumab (Ultomiris)[2]EMA authorisedcomplement-mediated thrombotic microangiopathy; complement inhibitor-naive or eculizumab-experienced state for ravulizumab where specified; EU marketing authorization for C5 inhibition in aHUS; England/NICE access conditions for eculizumab and ravulizumab. · EMA authorization does not equal automatic country reimbursement. NICE applies to England and is tied to expert-center/cohort monitoring or commercial arrangements. Ravulizumab has not been directly compared with eculizumab in NICE's rationale. Confidence/conflicts: High for EMA/NICE claims; no conflict identified, but Germany/France reimbursement remains unverified in this batch.
  • eculizumab (Soliris); ravulizumab (Ultomiris)[2]EMA authorisedcomplement-mediated thrombotic microangiopathy; complement inhibitor-naive or eculizumab-experienced state for ravulizumab where specified; EU marketing authorization for C5 inhibition in aHUS; England/NICE access conditions for eculizumab and ravulizumab. · EMA authorization does not equal automatic country reimbursement. NICE applies to England and is tied to expert-center/cohort monitoring or commercial arrangements. Ravulizumab has not been directly compared with eculizumab in NICE's rationale. Confidence/conflicts: High for EMA/NICE claims; no conflict identified, but Germany/France reimbursement remains unverified in this batch.

Australia

  • eculizumab (Soliris); ravulizumab (Ultomiris)[3]TGA-registered (Australia)complement-mediated TMA; source distinguishes aHUS from STEC-HUS in label context; complement inhibition for aHUS in Australia; ravulizumab PI/AusPAR context includes aHUS patients. · The fetched TGA sources support Australian aHUS regulator context but are not current PBS criteria. Current PI should be checked for exact ravulizumab aHUS indication wording, weight bands, and STEC-HUS limitation before patient-facing reuse. Confidence/conflicts: Medium-high for Australia eculizumab/ravulizumab aHUS regulator context; exact current ravulizumab indication wording and PBS criteria remain source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.

Thailand

  • ravulizumab (Ultomiris)[4]Approvedcomplement-mediated thrombotic microangiopathy context; source describes treatment to resolve thrombotic microangiopathy manifestations; adult and pediatric aHUS patients weighing at least 10 kg; complement-inhibitor-naive patients or eculizumab-experienced patients with response after at least 3 months. · Ravulizumab must be administered by a healthcare professional under supervision of a physician experienced in renal disorders. The label states aHUS treatment to resolve thrombotic microangiopathy manifestations should be for a minimum duration of 6 months, with longer treatment considered individually, and that higher-risk patients may require chronic therapy. It states pediatric safety and efficacy under 10 kg are not established. This entry does not establish Thai reimbursement, center availability, or diagnostic criteria beyond the label context. Confidence/conflicts: High for Thai NDI Ultomiris aHUS label content; no conflict identified. Reimbursement/access and Thailand diagnostic pathway remain unresolved.

Canada

  • eculizumab (Soliris)[5]Health Canada approvedcomplement-mediated thrombotic microangiopathy; STEC-HUS excluded by label limitation; aHUS to reduce complement-mediated TMA in Canada, including pediatric aHUS authorization. · Soliris has serious meningococcal infection precautions and should not be started in patients with unresolved Neisseria meningitidis infection or without current vaccination unless prophylactic antibiotics are used as specified by label. The source does not establish provincial reimbursement or transplant-specific protocols. Confidence/conflicts: High for Canadian Soliris aHUS label and STEC-HUS limitation; reimbursement/transplant pathway remains source-pending. No conflict identified.
  • ravulizumab (Ultomiris)[6]Health Canada approvedcomplement-mediated thrombotic microangiopathy; STEC-HUS excluded by label limitation; adult and pediatric patients 1 month and older with aHUS in Canada. · The monograph includes serious meningococcal infection warnings and vaccination/monitoring requirements. The RDS opened here was for a later gMG decision, so the aHUS claim is anchored to the current product monograph, not that RDS decision text. Confidence/conflicts: High for Canadian Ultomiris aHUS label; RDS is supportive for product record only, not the aHUS indication. No conflict identified. Availability/reimbursement outside the approving regulator not established.

출처

  1. U.S. Food and Drug Administration — official drug label · official drug label
  2. European Medicines Agency (EMA) — regulator product information · regulator product information
  3. Therapeutic Goods Administration (TGA) — Australian Product Information attachment to AusPAR · Australian Product Information attachment to AusPAR
  4. Thai National Drug Information / Thai FDA-MOPH — SmPC PDF / regulator drug-information repository · SmPC PDF / regulator drug-information repository
  5. Alexion Canada / Health Canada product monograph — official product monograph · official product monograph
  6. Alexion Canada / Health Canada product monograph — official product monograph · official product monograph

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.