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Atypical hemolytic uremic syndrome (aHUS): options by country

Sourced options by country plus visit-prep questions for Atypical hemolytic uremic syndrome (aHUS). Each line links to its regulator, HTA, or guideline source. This page maps options; it does not recommend or rank them.

Options mappedRare diseaseLast checked June 2026

What this page does

Maps options by country

It maps sourced options by country alongside diagnosis wording, stage, test results, specialists, and trial-search terms.

What it does not do

Does not choose treatment

It does not rank treatments, recommend a choice, or decide clinical fit.

Where it comes from

Built on trusted sources

Every option links to a trusted regulator, HTA, or guideline source, and the list grows as new sources pass verification.

Information to gather before the next visit

  • Has the team differentiated aHUS/complement-mediated TMA from STEC-HUS, TTP, cobalamin C defect, or other secondary TMA causes?
  • Which local pathway applies for Soliris versus Ultomiris, including REMS, vaccination, and urgent-start precautions?
  • Is the discussion about acute TMA control, chronic relapse prevention, transplant recurrence risk, or switching from eculizumab to ravulizumab?
  • Is the relevant decision an EMA authorization question or a national access/reimbursement question in England, France, Germany, or another EU country?

Trial-search terms to discuss

Atypical hemolytic uremic syndrome (aHUS) clinical trial

Options by country

Treatments by country

Regulatory and access status by country, from official sources. It shows what exists and where — not a recommendation.

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.

Sources

  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

This is official regulatory and access status only — not medical advice, not a recommendation, and not a statement about eligibility. Whether any option fits depends on your situation and your oncology team. Status changes over time; confirm the current position with the linked source. Last checked 2026-06-12.

Beyond approved care

In clinical trials & emerging options

Options that are not — or not yet — an approved standard where you live: studies, clinical trials, off-label use, and early evidence that your own oncologist may not raise. Each is labeled by how strong the evidence is. A listing here is information to research and discuss with your team; it does not mean a treatment is proven, safe for you, or available today.

In clinical trials

  • eculizumab (Soliris); ravulizumab (Ultomiris)Clinical trialClinical trialReported in a clinical trialJapan · complement-mediated thrombotic microangiopathy; Soliris for inhibition of TMA in aHUS; Japan eculizumab study and ravulizumab post-approval evidence context. · The PMDA document fetched is a later Soliris review report that includes existing aHUS indications; it is not the original 2013 aHUS approval review. Ravulizumab Japan status is supported here by peer-reviewed literature and multinational registry context, not direct PMDA label text in this pass. Confidence/conflicts: High for Soliris Japan aHUS approval context and Japan eculizumab study; medium for ravulizumab Japan approval until direct PMDA label/review is fetched. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report
  • eculizumab (Soliris); ravulizumab (Ultomiris)Clinical trialClinical trialReported in a clinical trialJapan · complement-mediated thrombotic microangiopathy; Soliris for inhibition of TMA in aHUS; Japan eculizumab study and ravulizumab post-approval evidence context. · The PMDA document fetched is a later Soliris review report that includes existing aHUS indications; it is not the original 2013 aHUS approval review. Ravulizumab Japan status is supported here by peer-reviewed literature and multinational registry context, not direct PMDA label text in this pass. Confidence/conflicts: High for Soliris Japan aHUS approval context and Japan eculizumab study; medium for ravulizumab Japan approval until direct PMDA label/review is fetched. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report
  • eculizumab (Soliris); eculizumab biosimilar context (Epysqli / eculizumab-aagh); ravulizumab/crovalimab investigational registry contextClinical trial · NCT05876351Clinical trialTrial only (NCT05876351)Korea · suspected or confirmed complement-mediated TMA; ADAMTS13 and STEC-HUS differential diagnosis emphasized in Korea guideline; Korea guideline first-line eculizumab for symptomatic aHUS; China eculizumab study in pediatric/adult aHUS; crovalimab investigational aHUS adult/adolescent and pediatric studies. · Korea approval/access claims rely on guideline and manufacturer biosimilar announcement, not direct MFDS label. China approval claim is manufacturer-sourced, not direct NMPA. Crovalimab registry entries do not establish routine approval. Confidence/conflicts: Medium for Korea/China local routine availability because direct MFDS/NMPA labels were not fetched; high for guideline and registry geography/status. Samsung Bioepis — manufacturer regulatory approval announcement
  • eculizumab (Soliris); eculizumab biosimilar context (Epysqli / eculizumab-aagh); ravulizumab/crovalimab investigational registry contextClinical trial · NCT05876351Clinical trialTrial only (NCT05876351)Korea · suspected or confirmed complement-mediated TMA; ADAMTS13 and STEC-HUS differential diagnosis emphasized in Korea guideline; Korea guideline first-line eculizumab for symptomatic aHUS; China eculizumab study in pediatric/adult aHUS; crovalimab investigational aHUS adult/adolescent and pediatric studies. · Korea approval/access claims rely on guideline and manufacturer biosimilar announcement, not direct MFDS label. China approval claim is manufacturer-sourced, not direct NMPA. Crovalimab registry entries do not establish routine approval. Confidence/conflicts: Medium for Korea/China local routine availability because direct MFDS/NMPA labels were not fetched; high for guideline and registry geography/status. Samsung Bioepis — manufacturer regulatory approval announcement
  • eculizumab (Soliris); eculizumab biosimilar context (Epysqli / eculizumab-aagh); ravulizumab/crovalimab investigational registry contextClinical trial · NCT05876351Clinical trialTrial only (NCT05876351)Korea · suspected or confirmed complement-mediated TMA; ADAMTS13 and STEC-HUS differential diagnosis emphasized in Korea guideline; Korea guideline first-line eculizumab for symptomatic aHUS; China eculizumab study in pediatric/adult aHUS; crovalimab investigational aHUS adult/adolescent and pediatric studies. · Korea approval/access claims rely on guideline and manufacturer biosimilar announcement, not direct MFDS label. China approval claim is manufacturer-sourced, not direct NMPA. Crovalimab registry entries do not establish routine approval. Confidence/conflicts: Medium for Korea/China local routine availability because direct MFDS/NMPA labels were not fetched; high for guideline and registry geography/status. Samsung Bioepis — manufacturer regulatory approval announcement
  • aHUS Registry observation; ravulizumab (Ultomiris); crovalimabClinical trial · NCT03131219Clinical trialTrial only (NCT03131219)Russia · complement-mediated TMA registry context; no intervention in registry-only aHUS Registry; Observational aHUS registry; pediatric/adolescent ravulizumab study; adult/adolescent and pediatric crovalimab investigational studies. · Registry/trial participation does not establish routine national availability. Russia has registry presence but no verified Russian regulator label or reimbursement source. Thailand remains source-pending for aHUS treatment/access. Confidence/conflicts: High for registry/trial geography/status; low for routine Russia/Thailand access because direct regulator or payer sources were not verified. trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — observational registry
  • aHUS Registry observation; ravulizumab (Ultomiris); crovalimabClinical trial · NCT03131219Clinical trialTrial only (NCT03131219)Russia · complement-mediated TMA registry context; no intervention in registry-only aHUS Registry; Observational aHUS registry; pediatric/adolescent ravulizumab study; adult/adolescent and pediatric crovalimab investigational studies. · Registry/trial participation does not establish routine national availability. Russia has registry presence but no verified Russian regulator label or reimbursement source. Thailand remains source-pending for aHUS treatment/access. Confidence/conflicts: High for registry/trial geography/status; low for routine Russia/Thailand access because direct regulator or payer sources were not verified. trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — observational registry
  • aHUS Registry observation; ravulizumab (Ultomiris); crovalimabClinical trial · NCT03131219Clinical trialTrial only (NCT03131219)Russia · complement-mediated TMA registry context; no intervention in registry-only aHUS Registry; Observational aHUS registry; pediatric/adolescent ravulizumab study; adult/adolescent and pediatric crovalimab investigational studies. · Registry/trial participation does not establish routine national availability. Russia has registry presence but no verified Russian regulator label or reimbursement source. Thailand remains source-pending for aHUS treatment/access. Confidence/conflicts: High for registry/trial geography/status; low for routine Russia/Thailand access because direct regulator or payer sources were not verified. trial-registry listing only — does not establish approval, reimbursement, or eligibility ClinicalTrials.gov — observational registry

A clinical-trial listing or early report shows an option is being studied — not that it works, that it is safe for any one person, or that a site is enrolling today. Whether any of these fits is a conversation for your oncology team and the trial team. Last checked 2026-06-12.