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Neurofibromatosis (NF1 / NF2): 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

Neurofibromatosis (NF1 / NF2) 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

  • selumetinib (Koselugo); mirdametinib (Gomekli)[1]FDA-approvedNF1 clinical/genetic condition; treatment indication in fetched labels is disease/manifestation-defined, not mutation-subtype-defined; Symptomatic, inoperable/not completely resectable NF1-associated plexiform neurofibromas. · Labels and approval notices include age, formulation, cardiac, ocular, dermatologic, gastrointestinal, laboratory, reproductive, and drug-interaction caveats. This entry does not imply use for cutaneous neurofibromas, optic pathway glioma, malignant peripheral nerve sheath tumor, or asymptomatic PN unless separately verified by a source. Confidence/conflicts: High for U.S. approved NF1-PN label status; no source conflict identified.

European Union

  • selumetinib (Koselugo)[2]EMA authorisedNF1 clinical/genetic condition; Symptomatic, inoperable NF1-associated PN; NICE guidance is specifically children aged 3 and over. · EMA authorization does not automatically establish reimbursement in Germany, France, or the UK. NICE HST20 is a UK access/guidance source for the stated pediatric scope and needs updating/expansion verification for adults after the recent EMA adult indication. Confidence/conflicts: High for EU authorization and NICE pediatric guidance; medium for adult UK access because current adult NICE commissioning was not verified this cycle.

Australia

  • selumetinib (Koselugo)[3]ApprovedNF1 clinical/genetic disorder context; no additional biomarker stated; Australian PBS pediatric NF1 plexiform neurofibroma access context. · Manufacturer source is not the PBS Schedule. Current authority criteria, adult access, and exact restriction wording require direct PBS verification. Confidence/conflicts: Medium-high for PBS listing announcement and pediatric access context; live PBS Schedule remains source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • selumetinib (Koselugo)[3]ApprovedNF1 clinical/genetic disorder context; no additional biomarker stated; Australian PBS pediatric NF1 plexiform neurofibroma access context. · Manufacturer source is not the PBS Schedule. Current authority criteria, adult access, and exact restriction wording require direct PBS verification. Confidence/conflicts: Medium-high for PBS listing announcement and pediatric access context; live PBS Schedule remains source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • selumetinib (Koselugo)[4]ApprovedNF1 clinical/genetic disorder context; Australian ARTG-linked label context for adult and pediatric NF1 symptomatic inoperable plexiform neurofibromas. · The healthdirect page is a consumer-facing ARTG-linked medicine page and does not establish PBS subsidy for adults or all listed ages. Monitoring, ocular/cardiac/laboratory/pregnancy caveats require the current PI. Confidence/conflicts: High for Australian ARTG-linked indication; PBS age/funding scope differs and is handled separately. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • selumetinib sulfate (Koselugo)[5]TGA-registered (Australia)NF1 clinical/genetic disorder context; no additional biomarker required by the fetched Australian sources; symptomatic, inoperable or not-completely-resectable plexiform neurofibromas in NF1, as stated by the Australian sources. · The TGA decision summary page documents the original pediatric approval; the fetched current product-information/medicine-information text documents the broader adult-and-pediatric wording. This entry records regulatory/label status only, not PBS subsidy status. Confidence/conflicts: Medium-high. The TGA decision summary and current medicine-information page differ in age-scope wording because the TGA page records the original approval while the medicine-information page reflects current adult/pediatric wording; no direct conflict in the pediatric setting. Availability/reimbursement outside the approving regulator not established.

Thailand

  • selumetinib as hydrogen sulfate (Koselugo)[6]ApprovedNF1; symptomatic, inoperable plexiform neurofibromas as specified by the source; pediatric NF1 patients aged 3 years and above with symptomatic, inoperable plexiform neurofibromas; monotherapy per AstraZeneca Thailand abbreviated PI. · The AstraZeneca Thailand page is manufacturer/HCP promotional-medical content, not the full Thai FDA label; it states the advertisement is the advertiser's responsibility and is intended for healthcare professionals in Thailand. It states the product is a new medicine for hospital use only, pediatric use under age 3 is not established, data older than 18 years are limited, starting treatment in adults is not appropriate in that PI, and monitoring warnings include left-ventricular ejection fraction, ocular toxicity, liver laboratory abnormalities, skin/subcutaneous adverse reactions, vitamin E/bleeding considerations, swallowing/choking risk, and reproductive precautions. This entry does not establish Thai reimbursement or hospital access. Confidence/conflicts: Medium-high: Thai NDI verifies registration numbers and AstraZeneca Thailand verifies the Thailand pediatric NF1-PN indication; no conflict identified, but the full Thai FDA label was not accessible without login and reimbursement remains unresolved.

Canada

  • MRI monitoring, surgery, radiation therapy, cochlear implant, auditory brainstem implant, bevacizumab (Avastin) case-by-case context[7]Standard option (per Tumour Foundation of British Columbia)NF2-related schwannomatosis clinical/genetic condition; British Columbia supportive/specialist pathway for NF2-SWN hearing impairment, vestibular schwannoma monitoring, tumour management, and selected medical therapy discussion. · This is a provincial patient/physician guide, not a regulator label or payer rule. Bevacizumab is not recorded here as an approved NF2 drug; the source itself flags limited Canadian availability and case-by-case evaluation. Confidence/conflicts: Medium-high for BC supportive pathway; drug access for bevacizumab remains uncertain and source itself flags limited availability. No conflict identified.
  • MRI monitoring, surgery, radiation therapy, cochlear implant, auditory brainstem implant, bevacizumab (Avastin) case-by-case context[7]Standard option (per Tumour Foundation of British Columbia)NF2-related schwannomatosis clinical/genetic condition; British Columbia supportive/specialist pathway for NF2-SWN hearing impairment, vestibular schwannoma monitoring, tumour management, and selected medical therapy discussion. · This is a provincial patient/physician guide, not a regulator label or payer rule. Bevacizumab is not recorded here as an approved NF2 drug; the source itself flags limited Canadian availability and case-by-case evaluation. Confidence/conflicts: Medium-high for BC supportive pathway; drug access for bevacizumab remains uncertain and source itself flags limited availability. No conflict identified.
  • MRI monitoring, surgery, radiation therapy, cochlear implant, auditory brainstem implant, bevacizumab (Avastin) case-by-case context[7]Standard option (per Tumour Foundation of British Columbia)NF2-related schwannomatosis clinical/genetic condition; British Columbia supportive/specialist pathway for NF2-SWN hearing impairment, vestibular schwannoma monitoring, tumour management, and selected medical therapy discussion. · This is a provincial patient/physician guide, not a regulator label or payer rule. Bevacizumab is not recorded here as an approved NF2 drug; the source itself flags limited Canadian availability and case-by-case evaluation. Confidence/conflicts: Medium-high for BC supportive pathway; drug access for bevacizumab remains uncertain and source itself flags limited availability. No conflict identified.
  • MRI monitoring, surgery, radiation therapy, cochlear implant, auditory brainstem implant, bevacizumab (Avastin) case-by-case context[7]Standard option (per Tumour Foundation of British Columbia)NF2-related schwannomatosis clinical/genetic condition; British Columbia supportive/specialist pathway for NF2-SWN hearing impairment, vestibular schwannoma monitoring, tumour management, and selected medical therapy discussion. · This is a provincial patient/physician guide, not a regulator label or payer rule. Bevacizumab is not recorded here as an approved NF2 drug; the source itself flags limited Canadian availability and case-by-case evaluation. Confidence/conflicts: Medium-high for BC supportive pathway; drug access for bevacizumab remains uncertain and source itself flags limited availability. No conflict identified.
  • selumetinib (Koselugo)[8]Health Canada approvedNF1 clinical/genetic disorder context; no additional biomarker required by the fetched Canadian product monograph; pediatric patients aged 2 years and above with symptomatic, inoperable plexiform neurofibromas in NF1, as stated by the Canadian product monograph. · The Canadian product monograph states Health Canada has not authorized a geriatric indication and frames the indication as pediatric. This entry records Health Canada label status, not provincial reimbursement or individual eligibility. Confidence/conflicts: High for Canadian pediatric label status; no conflict identified in the fetched Health Canada portal and product monograph.
  • selumetinib (Koselugo)[9]ApprovedNF1 clinical/genetic disorder context; Canadian HTA/reimbursement-review context for pediatric NF1 patients with symptomatic, inoperable plexiform neurofibromas. · CADTH/NCBI review material is a reimbursement and evidence assessment, not a prescribing label. It flags uncertainty in comparative evidence and cost-effectiveness; it does not establish that any individual person can access treatment. Confidence/conflicts: Medium-high for Canadian HTA caveats; no conflict identified with Health Canada approval because HTA/reimbursement review addresses evidence and funding uncertainty rather than market authorization.
  • selumetinib (Koselugo)[9]ApprovedNF1 clinical/genetic disorder context; Canadian HTA/reimbursement-review context for pediatric NF1 patients with symptomatic, inoperable plexiform neurofibromas. · CADTH/NCBI review material is a reimbursement and evidence assessment, not a prescribing label. It flags uncertainty in comparative evidence and cost-effectiveness; it does not establish that any individual person can access treatment. Confidence/conflicts: Medium-high for Canadian HTA caveats; no conflict identified with Health Canada approval because HTA/reimbursement review addresses evidence and funding uncertainty rather than market authorization.
  • selumetinib (Koselugo)[10]Health Canada approvedNF1 clinical/genetic disorder context; Canadian national HTA/reimbursement context for pediatric NF1 symptomatic inoperable plexiform neurofibromas. · The fetched PDF is marked draft; final/current CDA-AMC recommendation and provincial implementation must be verified before recording live coverage. CADTH notes uncertainty about how tumour-volume changes correlate with symptoms or function. Confidence/conflicts: Medium because the recommendation PDF is draft and provincial implementation is unverified; Health Canada pediatric label context was previously verified. No conflict identified.
  • selumetinib (Koselugo)[10]Health Canada approvedNF1 clinical/genetic disorder context; Canadian national HTA/reimbursement context for pediatric NF1 symptomatic inoperable plexiform neurofibromas. · The fetched PDF is marked draft; final/current CDA-AMC recommendation and provincial implementation must be verified before recording live coverage. CADTH notes uncertainty about how tumour-volume changes correlate with symptoms or function. Confidence/conflicts: Medium because the recommendation PDF is draft and provincial implementation is unverified; Health Canada pediatric label context was previously verified. No conflict identified.

출처

  1. DailyMed / U.S. National Library of Medicine — official drug label · official drug label
  2. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  3. AstraZeneca Australia — manufacturer PBS listing announcement · manufacturer PBS listing announcement
  4. Healthdirect Australia / ARTG-linked medicine page — medicine information / ARTG extract · medicine information / ARTG extract
  5. Therapeutic Goods Administration (TGA) — regulator public assessment/decision summary · regulator public assessment/decision summary
  6. Thai National Drug Information / Thai FDA-MOPH — drug registration listing · drug registration listing
  7. Tumour Foundation of British Columbia — physician guide / patient-advocacy clinical resource · physician guide / patient-advocacy clinical resource
  8. Health Canada Drug and Health Product Portal — regulator product portal · regulator product portal
  9. CADTH via NCBI Bookshelf — pharmacoeconomic/reimbursement review · pharmacoeconomic/reimbursement review
  10. CADTH / Canada's Drug Agency — draft reimbursement recommendation · draft reimbursement recommendation

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.