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"manufacturer": "Volifil", "category": "filler", "categoryLabel": "Dermal filler", "activeIngredient": null, "evidenceStatus": "catalog-identity", "detailUrl": "https://aestheticpass.com/products/volifil-deep-lidocaine/", "profileUrl": null, "snapshotDate": "2026-08-14" }, { "id": "catalog:volifil-sub-q-lidocaine", "name": "Volifil Sub-Q Lidocaine", "manufacturer": "Volifil", "category": "filler", "categoryLabel": "Dermal filler", "activeIngredient": null, "evidenceStatus": "catalog-identity", "detailUrl": "https://aestheticpass.com/products/volifil-sub-q-lidocaine/", "profileUrl": null, "snapshotDate": "2026-08-14" }, { "id": "catalog:volus-10", "name": "Volus 10", "manufacturer": "Volus", "category": "filler", "categoryLabel": "Dermal filler", "activeIngredient": null, "evidenceStatus": "catalog-identity", "detailUrl": "https://aestheticpass.com/products/volus-10/", "profileUrl": null, "snapshotDate": "2026-08-14" }, { "id": "catalog:yellowshot", "name": "Yellowshot", "manufacturer": "USKIN", "category": "fat_dissolver", "categoryLabel": "Fat-dissolving injectable", "activeIngredient": null, "evidenceStatus": "catalog-identity", "detailUrl": "https://aestheticpass.com/products/yellowshot/", "profileUrl": null, "snapshotDate": "2026-08-14" } ], "profiles": [ { "slug": "botox", "name": "Botox / Vistabel", "manufacturer": "AbbVie (Allergan Aesthetics)", "classification": "Botulinum toxin type A brand identity", "aliases": [ { "name": "Botox Cosmetic", "scope": "United States brand name" }, { "name": "Vistabel", "scope": "Brand name used in selected European markets" } ], "materialNames": [ "onabotulinumtoxinA" ], "sourceCount": 3, "sourceJurisdictions": [ "United States", "France" ], "sources": [ { "id": "allergan-botox-cosmetic-us", "title": "Botox Cosmetic official site", "publisher": "Allergan Aesthetics, an AbbVie company", "url": "https://www.botoxcosmetic.com/", "kind": "manufacturer", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Botox Cosmetic brand identity and United States product context." }, { "id": "fr-public-medicines-vistabel", "title": "VISTABEL 4 Allergan units / 0.1 ml — public medicine record and RCP", "publisher": "French Public Medicines Database / ANSM", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/68150775/extrait", "kind": "regulator", "jurisdiction": "France", "checkedAt": "2026-08-14", "supports": "The current French VISTABEL name, prescription status, authorisation record, presentation, and botulinum-toxin-type-A identity." }, { "id": "dailymed-botox-cosmetic-us", "title": "BOTOX Cosmetic — current United States drug label", "publisher": "U.S. National Library of Medicine (DailyMed)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=485d9b71-6881-42c5-a620-a4360c7192ab", "kind": "approved-label", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The current United States BOTOX Cosmetic identity, labeler, prescription-label context, and onabotulinumtoxinA naming." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "France and United States identity records are attached; the profile still requires named clinical review.", "jurisdictions": [ { "code": "FR", "name": "France", "productNames": [ "Vistabel" ], "evidenceLevel": "regulator-record", "sourceIds": [ "fr-public-medicines-vistabel" ], "finding": "The French public medicines database records VISTABEL as a prescription medicinal product containing botulinum toxin type A.", "limitation": "This is a France-specific record for the named presentation; it does not establish another market's label or units." }, { "code": "US", "name": "United States", "productNames": [ "BOTOX Cosmetic" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "dailymed-botox-cosmetic-us" ], "finding": "Current United States labeling identifies BOTOX Cosmetic and the nonproprietary name onabotulinumtoxinA.", "limitation": "The United States label does not establish equivalence with Vistabel or any other botulinum-toxin presentation." } ], "claims": [ { "id": "botox-market-names", "kind": "alias", "statement": "BOTOX Cosmetic and Vistabel are documented market-scoped brand identities in this discovery profile.", "scope": "Alias grouping only; no interchangeability of product, presentation, unit, label, or authorised use is claimed.", "sourceIds": [ "fr-public-medicines-vistabel", "dailymed-botox-cosmetic-us" ] }, { "id": "botox-active-name", "kind": "material", "statement": "The United States source names onabotulinumtoxinA; the French source names botulinum toxin type A.", "scope": "Source terminology is preserved by jurisdiction and is not used for dose conversion.", "sourceIds": [ "fr-public-medicines-vistabel", "dailymed-botox-cosmetic-us" ] } ], "reviewerFocus": [ "Verify that the grouped legacy URL does not imply that Allergan units or presentations are interchangeable across markets." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/botox/" }, { "slug": "dysport", "name": "Dysport / Azzalure", "manufacturer": "Galderma (licensed from Ipsen)", "classification": "Botulinum toxin type A brand identity", "aliases": [ { "name": "Dysport", "scope": "International brand name" }, { "name": "Azzalure", "scope": "Aesthetic brand name in European markets" } ], "materialNames": [ "abobotulinumtoxinA" ], "sourceCount": 3, "sourceJurisdictions": [ "European Union / international", "United Kingdom", "United States" ], "sources": [ { "id": "galderma-azzalure", "title": "Azzalure", "publisher": "Galderma", "url": "https://www.galderma.com/azzalure", "kind": "manufacturer", "jurisdiction": "European Union / international", "checkedAt": "2026-08-14", "supports": "Azzalure identity and its naming relationship with Dysport in aesthetic markets." }, { "id": "emc-azzalure-smpc", "title": "Azzalure 125 Speywood units — Summary of Product Characteristics", "publisher": "electronic Medicines Compendium", "url": "https://www.medicines.org.uk/emc/product/6584/smpc", "kind": "approved-label", "jurisdiction": "United Kingdom", "checkedAt": "2026-08-14", "supports": "Current UK prescribing-information context for the named product presentation." }, { "id": "dailymed-dysport-us", "title": "DYSPORT — United States drug label", "publisher": "U.S. National Library of Medicine (DailyMed)", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=71313a04-1349-4c26-b840-a39e4a3ddaed", "kind": "approved-label", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The United States DYSPORT identity, Galderma labeler context, and abobotulinumtoxinA naming." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "Approved product information is attached for Azzalure in the UK and Dysport in the US.", "jurisdictions": [ { "code": "UK", "name": "United Kingdom", "productNames": [ "Azzalure" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "emc-azzalure-smpc" ], "finding": "The current UK SmPC records Azzalure 125 Speywood units as a prescription medicinal product containing botulinum toxin type A.", "limitation": "The record is specific to the UK presentation and its Speywood-unit convention." }, { "code": "US", "name": "United States", "productNames": [ "Dysport" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "dailymed-dysport-us" ], "finding": "United States labeling records DYSPORT and the nonproprietary name abobotulinumtoxinA.", "limitation": "The source does not make United States DYSPORT interchangeable with UK Azzalure or other toxin products." } ], "claims": [ { "id": "dysport-azzalure-names", "kind": "alias", "statement": "Dysport and Azzalure are separately documented names within the Galderma / Ipsen product family.", "scope": "Discovery relationship only; jurisdictional presentation and unit differences remain explicit.", "sourceIds": [ "galderma-azzalure", "emc-azzalure-smpc", "dailymed-dysport-us" ] }, { "id": "dysport-active-name", "kind": "material", "statement": "The US label uses abobotulinumtoxinA, while the UK SmPC uses botulinum toxin type A and presentation-specific Speywood units.", "scope": "Terminology is reported from each source without a conversion claim.", "sourceIds": [ "emc-azzalure-smpc", "dailymed-dysport-us" ] } ], "reviewerFocus": [ "Check that the family wording never collapses Speywood units into another manufacturer's potency units." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/dysport/" }, { "slug": "letybo", "name": "Letybo", "manufacturer": "Hugel / Croma-Pharma", "classification": "Botulinum toxin type A brand identity", "aliases": [], "materialNames": [ "letibotulinumtoxinA", "botulinum toxin type A" ], "sourceCount": 4, "sourceJurisdictions": [ "Germany", "United States", "United Kingdom" ], "sources": [ { "id": "croma-letybo-de-pil", "title": "Letybo 50 units — patient information leaflet", "publisher": "Croma Deutschland GmbH via PatientenInfo-Service", "url": "https://www.patienteninfo-service.de/gi/18452/pdf", "kind": "approved-label", "jurisdiction": "Germany", "checkedAt": "2026-08-14", "supports": "German product name, presentation, active-component wording, and leaflet revision context." }, { "id": "croma-letybo-fda-announcement", "title": "Letybo receives FDA approval", "publisher": "Croma-Pharma", "url": "https://www.cromapharma.com/at/ueber-croma/presse-und-downloads/letybo-receives-fda-approval-for-the-treatment-of-glabellar-lines/", "kind": "manufacturer", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Manufacturer relationship and United States brand context." }, { "id": "emc-letybo-uk-smpc", "title": "Letybo 50 units — Summary of Product Characteristics", "publisher": "electronic Medicines Compendium", "url": "https://www.medicines.org.uk/emc/product/13707/smpc", "kind": "approved-label", "jurisdiction": "United Kingdom", "checkedAt": "2026-08-14", "supports": "The current UK product name, presentation, botulinum-toxin-type-A composition wording, and prescription context." }, { "id": "dailymed-letybo-us", "title": "LETYBO — current United States drug label", "publisher": "U.S. National Library of Medicine (DailyMed)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=910e5d0e-4d0b-4de8-8e2d-97879a044181", "kind": "approved-label", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The United States LETYBO identity, Hugel packager context, and letibotulinumtoxinA-wlbg naming." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "Current product information is mapped for Germany, the UK, and the US.", "jurisdictions": [ { "code": "DE", "name": "Germany", "productNames": [ "Letybo" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "croma-letybo-de-pil" ], "finding": "German patient information documents Letybo 50 units and botulinum toxin type A for Croma Deutschland GmbH.", "limitation": "The linked German leaflet is presentation-specific and does not establish another country's label." }, { "code": "UK", "name": "United Kingdom", "productNames": [ "Letybo" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "emc-letybo-uk-smpc" ], "finding": "The UK SmPC records Letybo 50 units as a prescription medicinal product containing botulinum toxin type A.", "limitation": "UK product information must not be generalised to Germany, the US, or another presentation." }, { "code": "US", "name": "United States", "productNames": [ "LETYBO" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "dailymed-letybo-us" ], "finding": "United States labeling records LETYBO with the nonproprietary name letibotulinumtoxinA-wlbg.", "limitation": "The US proper name and label context are market-specific." } ], "claims": [ { "id": "letybo-three-market-identity", "kind": "identity", "statement": "Letybo is documented by current product-information sources in Germany, the United Kingdom, and the United States.", "scope": "The statement covers identity presence in the cited sources, not identical presentations or authorised uses.", "sourceIds": [ "croma-letybo-de-pil", "emc-letybo-uk-smpc", "dailymed-letybo-us" ] }, { "id": "letybo-active-names", "kind": "material", "statement": "European sources use botulinum toxin type A wording; the US label uses letibotulinumtoxinA-wlbg.", "scope": "Names are transcribed by source market without an equivalence or conversion claim.", "sourceIds": [ "croma-letybo-de-pil", "emc-letybo-uk-smpc", "dailymed-letybo-us" ] } ], "reviewerFocus": [ "Review the distinction between European composition wording and the US nonproprietary suffix." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/letybo/" }, { "slug": "xeomin", "name": "Xeomin / Bocouture", "manufacturer": "Merz Aesthetics", "classification": "Botulinum toxin type A brand identity", "aliases": [ { "name": "Xeomin", "scope": "United States brand name in the attached source" }, { "name": "Bocouture", "scope": "United Kingdom brand name in the attached source" } ], "materialNames": [ "incobotulinumtoxinA" ], "sourceCount": 3, "sourceJurisdictions": [ "United States", "United Kingdom" ], "sources": [ { "id": "merz-xeomin-aesthetic-us", "title": "Xeomin Aesthetic official site", "publisher": "Merz Aesthetics", "url": "https://www.xeominaesthetic.com/", "kind": "manufacturer", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Xeomin brand identity and United States manufacturer context." }, { "id": "emc-bocouture-uk-smpc", "title": "BOCOUTURE 50 units — Summary of Product Characteristics", "publisher": "electronic Medicines Compendium", "url": "https://www.medicines.org.uk/emc/product/600/smpc", "kind": "approved-label", "jurisdiction": "United Kingdom", "checkedAt": "2026-08-14", "supports": "The UK BOCOUTURE identity, Merz Aesthetics UK company context, presentation, and botulinum-toxin-type-A wording." }, { "id": "dailymed-xeomin-us", "title": "XEOMIN — current United States drug label", "publisher": "U.S. National Library of Medicine (DailyMed)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ccdc3aae-6e2d-4cd0-a51c-8375bfee9458", "kind": "approved-label", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The current US XEOMIN identity, Merz packager context, and incobotulinumtoxinA naming." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "UK BOCOUTURE and US XEOMIN product information are attached and separately scoped.", "jurisdictions": [ { "code": "UK", "name": "United Kingdom", "productNames": [ "BOCOUTURE" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "emc-bocouture-uk-smpc" ], "finding": "The UK SmPC records BOCOUTURE as a prescription medicinal product containing botulinum toxin type A free from complexing proteins.", "limitation": "The record supports BOCOUTURE in the UK, not the XEOMIN name or every Merz presentation globally." }, { "code": "US", "name": "United States", "productNames": [ "XEOMIN" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "dailymed-xeomin-us" ], "finding": "Current United States labeling records XEOMIN and the nonproprietary name incobotulinumtoxinA.", "limitation": "The United States label remains distinct from the UK BOCOUTURE product information." } ], "claims": [ { "id": "xeomin-bocouture-names", "kind": "alias", "statement": "XEOMIN and BOCOUTURE are separately documented Merz brand identities used in the US and UK source contexts.", "scope": "The atlas groups the names for discovery and does not assert presentation or label equivalence.", "sourceIds": [ "emc-bocouture-uk-smpc", "dailymed-xeomin-us" ] }, { "id": "xeomin-active-name", "kind": "material", "statement": "The US source uses incobotulinumtoxinA; the UK source uses botulinum toxin type A wording.", "scope": "Source terminology only; no dose or unit conversion is provided.", "sourceIds": [ "emc-bocouture-uk-smpc", "dailymed-xeomin-us" ] } ], "reviewerFocus": [ "Confirm that adding BOCOUTURE as a market-scoped alias does not imply identical national labeling." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/xeomin/" }, { "slug": "juvederm", "name": "Juvéderm", "manufacturer": "AbbVie (Allergan Aesthetics)", "classification": "Hyaluronic-acid dermal filler family", "aliases": [ { "name": "Juvederm", "scope": "Unaccented catalogue spelling" } ], "materialNames": [ "hyaluronic acid" ], "sourceCount": 3, "sourceJurisdictions": [ "United States" ], "sources": [ { "id": "allergan-juvederm-family-us", "title": "About the Juvéderm filler collection", "publisher": "Allergan Aesthetics, an AbbVie company", "url": "https://www.juvederm.com/about-juvederm", "kind": "manufacturer", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Juvéderm family identity, named family context, and hyaluronic-acid material class." }, { "id": "fda-approved-fillers", "title": "FDA-approved dermal fillers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers", "kind": "regulator", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Regulatory-method context and the requirement to verify individual filler records and labels." }, { "id": "fda-pma-juvederm-p050047", "title": "JUVEDERM gel implants — PMA P050047", "publisher": "U.S. Food and Drug Administration", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050047", "kind": "regulator", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The original US PMA family record, applicant identity, generic device class, and links to supplements and labeling." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "The US family context is anchored to an FDA PMA record and current manufacturer material.", "jurisdictions": [ { "code": "US", "name": "United States", "productNames": [ "JUVEDERM gel implants", "JUVÉDERM collection" ], "evidenceLevel": "regulator-record", "sourceIds": [ "fda-pma-juvederm-p050047", "allergan-juvederm-family-us" ], "finding": "The FDA PMA database records JUVEDERM gel implants under P050047, while the current manufacturer page documents the US collection and hyaluronic-acid family context.", "limitation": "A family PMA record does not verify every catalogue variant, formulation, supplement, or non-US presentation." } ], "claims": [ { "id": "juvederm-family-identity", "kind": "identity", "statement": "Juvéderm is a product-family identity with multiple separately named variants in the operational catalogue.", "scope": "Variants remain distinct records; the family page does not collapse their formulations or labels.", "sourceIds": [ "fda-pma-juvederm-p050047", "allergan-juvederm-family-us" ] }, { "id": "juvederm-material-family", "kind": "material", "statement": "The cited US manufacturer material describes the Juvéderm collection as a hyaluronic-acid filler family.", "scope": "Family-level material class only; exact composition must be checked in variant-specific labeling.", "sourceIds": [ "allergan-juvederm-family-us" ] } ], "reviewerFocus": [ "Check every matched catalogue name and flag variants that need their own PMA supplement or local IFU before variant-level publication." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/juvederm/" }, { "slug": "restylane", "name": "Restylane", "manufacturer": "Galderma", "classification": "Hyaluronic-acid dermal filler family", "aliases": [], "materialNames": [ "hyaluronic acid" ], "sourceCount": 3, "sourceJurisdictions": [ "United States" ], "sources": [ { "id": "galderma-restylane-science-us", "title": "Restylane science and technology", "publisher": "Galderma", "url": "https://www.restylaneusa.com/restylane-science", "kind": "manufacturer", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Restylane family identity, named technologies, and hyaluronic-acid material class." }, { "id": "fda-approved-fillers", "title": "FDA-approved dermal fillers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers", "kind": "regulator", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Regulatory-method context and the requirement to verify individual filler records and labels." }, { "id": "fda-pma-restylane-p040024", "title": "RESTYLANE injectable gel — PMA P040024", "publisher": "U.S. Food and Drug Administration", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040024", "kind": "regulator", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The original US Restylane PMA record, Q-Med applicant identity, generic device class, and supplement history." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "The US family context is anchored to FDA PMA P040024 and manufacturer family material.", "jurisdictions": [ { "code": "US", "name": "United States", "productNames": [ "Restylane injectable gel", "Restylane collection" ], "evidenceLevel": "regulator-record", "sourceIds": [ "fda-pma-restylane-p040024", "galderma-restylane-science-us" ], "finding": "The FDA PMA database records Restylane injectable gel under P040024, and Galderma documents the current US family and hyaluronic-acid technology context.", "limitation": "The PMA has many supplements; family evidence does not verify each catalogue spelling, variant, or current label." } ], "claims": [ { "id": "restylane-family-identity", "kind": "identity", "statement": "Restylane is a family identity spanning multiple named catalogue variants.", "scope": "Each variant remains a separate identity requiring product-specific evidence for variant-level claims.", "sourceIds": [ "fda-pma-restylane-p040024", "galderma-restylane-science-us" ] }, { "id": "restylane-material-family", "kind": "material", "statement": "The linked family sources place Restylane in the hyaluronic-acid dermal-filler class.", "scope": "This does not state the concentration, cross-linking, lidocaine content, or indication of a specific variant.", "sourceIds": [ "fda-pma-restylane-p040024", "galderma-restylane-science-us" ] } ], "reviewerFocus": [ "Review catalogue spelling variants such as Classyc and Volyme separately from the US family record." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/restylane/" }, { "slug": "radiesse", "name": "Radiesse", "manufacturer": "Merz Aesthetics", "classification": "Calcium-hydroxylapatite injectable family", "aliases": [], "materialNames": [ "calcium hydroxylapatite" ], "sourceCount": 3, "sourceJurisdictions": [ "United States" ], "sources": [ { "id": "fda-radiesse-us-ifu", "title": "Radiesse injectable implant — instructions for use", "publisher": "U.S. Food and Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050052S162D.pdf", "kind": "instructions-for-use", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Named product identity and calcium-hydroxylapatite material description for the labelled presentation." }, { "id": "fda-approved-fillers", "title": "FDA-approved dermal fillers", "publisher": "U.S. Food and Drug Administration", "url": "https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers", "kind": "regulator", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Regulatory-method context and the requirement to verify individual filler records and labels." }, { "id": "fda-pma-radiesse-p050052", "title": "RADIESSE injectable implant — PMA P050052", "publisher": "U.S. Food and Drug Administration", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?PMANumber=P050052&SupplementNumber=&start_search=1", "kind": "regulator", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The US Radiesse PMA family and supplement record for an aesthetic dermal implant." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "A current FDA IFU and PMA family record support the US identity and material class.", "jurisdictions": [ { "code": "US", "name": "United States", "productNames": [ "RADIESSE Injectable Implant" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "fda-radiesse-us-ifu", "fda-pma-radiesse-p050052" ], "finding": "Current FDA-hosted instructions identify RADIESSE Injectable Implant as calcium-hydroxylapatite microspheres in an aqueous gel carrier, linked to PMA P050052.", "limitation": "The source is US-specific and does not automatically cover every lidocaine, body-area, or non-US variant." } ], "claims": [ { "id": "radiesse-identity", "kind": "identity", "statement": "Radiesse is documented in the US as an injectable implant family with a PMA supplement history.", "scope": "The statement does not treat every supplement or catalogue variant as the same presentation.", "sourceIds": [ "fda-radiesse-us-ifu", "fda-pma-radiesse-p050052" ] }, { "id": "radiesse-material", "kind": "material", "statement": "The current FDA-hosted IFU describes calcium-hydroxylapatite microspheres in an aqueous gel carrier.", "scope": "Material identity for the cited US presentation only.", "sourceIds": [ "fda-radiesse-us-ifu" ] } ], "reviewerFocus": [ "Check that the operational booster category is clearly separated from FDA device classification and exact label scope." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/radiesse/" }, { "slug": "sculptra", "name": "Sculptra", "manufacturer": "Galderma", "classification": "Poly-L-lactic-acid injectable family", "aliases": [], "materialNames": [ "poly-L-lactic acid", "PLLA" ], "sourceCount": 3, "sourceJurisdictions": [ "International overview", "United States" ], "sources": [ { "id": "galderma-sculptra-global", "title": "Sculptra", "publisher": "Galderma", "url": "https://www.galderma.com/sculptra", "kind": "manufacturer", "jurisdiction": "International overview", "checkedAt": "2026-08-14", "supports": "Sculptra brand identity and poly-L-lactic-acid material class." }, { "id": "galderma-sculptra-us-ifu", "title": "Sculptra — United States instructions for use", "publisher": "Galderma", "url": "https://www.galderma.com/us/sites/default/files/2023-04/Sculptra_USA_eIFU.pdf", "kind": "instructions-for-use", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Labelled product identity, composition, and United States device context." }, { "id": "fda-pma-sculptra-p030050", "title": "SCULPTRA injectable poly-L-lactic acid — PMA P030050", "publisher": "U.S. Food and Drug Administration", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?PMANumber=P030050&SupplementNumber=&start_search=1", "kind": "regulator", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The US Sculptra PMA family record and its continuing supplement history." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "FDA PMA and IFU sources are attached alongside current Galderma family material.", "jurisdictions": [ { "code": "US", "name": "United States", "productNames": [ "Sculptra", "Sculptra Aesthetic" ], "evidenceLevel": "regulator-record", "sourceIds": [ "fda-pma-sculptra-p030050", "galderma-sculptra-us-ifu" ], "finding": "FDA records link Sculptra and Sculptra Aesthetic identities to PMA P030050 and poly-L-lactic-acid device information.", "limitation": "The PMA supplement history must be consulted for the current exact presentation and labeling." }, { "code": "INTL", "name": "International / source market not limited to one jurisdiction", "productNames": [ "Sculptra" ], "evidenceLevel": "manufacturer-documentation", "sourceIds": [ "galderma-sculptra-global" ], "finding": "Galderma's international product page documents the Sculptra family and PLLA material class.", "limitation": "An international manufacturer overview is not a jurisdiction-specific regulatory record." } ], "claims": [ { "id": "sculptra-family-identity", "kind": "material", "statement": "Sculptra is documented as an injectable poly-L-lactic-acid product family.", "scope": "Identity and material class only; no protocol, duration, outcome, or suitability claim is made.", "sourceIds": [ "fda-pma-sculptra-p030050", "galderma-sculptra-global", "galderma-sculptra-us-ifu" ] }, { "id": "sculptra-us-record", "kind": "identity", "statement": "The FDA PMA database maintains P030050 and its supplement history for the Sculptra family.", "scope": "US regulatory record only; the latest supplement and labeling govern the exact product context.", "sourceIds": [ "fda-pma-sculptra-p030050" ] } ], "reviewerFocus": [ "Confirm that older IFU material is framed as one record within an evolving PMA supplement history." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/sculptra/" }, { "slug": "belotero", "name": "Belotero", "manufacturer": "Merz Aesthetics", "classification": "Hyaluronic-acid dermal filler family", "aliases": [], "materialNames": [ "hyaluronic acid" ], "sourceCount": 3, "sourceJurisdictions": [ "Asia-Pacific product overview", "United States" ], "sources": [ { "id": "merz-belotero-family", "title": "Belotero product range", "publisher": "Merz Aesthetics", "url": "https://www.belotero.com/ap/products/", "kind": "manufacturer", "jurisdiction": "Asia-Pacific product overview", "checkedAt": "2026-08-14", "supports": "Belotero family identity, named range context, and hyaluronic-acid material class." }, { "id": "merz-belotero-balance-us-label", "title": "Belotero Balance — physician labelling", "publisher": "Merz North America", "url": "https://www.belotero.com/app/uploads/2023/05/IN00203-01.pdf", "kind": "approved-label", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "Product-specific identity and composition for Belotero Balance in the United States." }, { "id": "fda-pma-belotero-p090016", "title": "BELOTERO BALANCE — PMA P090016", "publisher": "U.S. Food and Drug Administration", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090016", "kind": "regulator", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The US Belotero Balance PMA family record and supplement history." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "The family is supported by manufacturer material and an FDA PMA / labeling record for Belotero Balance.", "jurisdictions": [ { "code": "US", "name": "United States", "productNames": [ "Belotero Balance", "Belotero Balance (+)" ], "evidenceLevel": "regulator-record", "sourceIds": [ "fda-pma-belotero-p090016", "merz-belotero-balance-us-label" ], "finding": "FDA records document Belotero Balance under PMA P090016, with product-specific US labeling available for the Balance presentation.", "limitation": "This evidence does not verify the other Belotero variants listed in the operational catalogue." }, { "code": "INTL", "name": "International / source market not limited to one jurisdiction", "productNames": [ "Belotero range" ], "evidenceLevel": "manufacturer-documentation", "sourceIds": [ "merz-belotero-family" ], "finding": "Merz's Asia-Pacific product overview documents multiple Belotero family names and a hyaluronic-acid material class.", "limitation": "The manufacturer overview is not a regulator record and does not establish availability or labeling in another jurisdiction." } ], "claims": [ { "id": "belotero-family-identity", "kind": "identity", "statement": "Belotero is a family identity with multiple separately named catalogue variants.", "scope": "Only Belotero Balance currently has product-specific US regulatory evidence in this dossier.", "sourceIds": [ "fda-pma-belotero-p090016", "merz-belotero-family", "merz-belotero-balance-us-label" ] }, { "id": "belotero-material-family", "kind": "material", "statement": "The cited family and Balance sources place the reviewed records in the hyaluronic-acid filler class.", "scope": "No exact composition is inferred for Intense, Lips, Revive, Soft, or Volume variants.", "sourceIds": [ "merz-belotero-family", "merz-belotero-balance-us-label" ] } ], "reviewerFocus": [ "Decide whether the family page can publish before variant-level IFUs are attached for the non-Balance catalogue records." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/belotero/" }, { "slug": "profhilo", "name": "Profhilo", "manufacturer": "IBSA Derma", "classification": "Hyaluronic-acid injectable family", "aliases": [], "materialNames": [ "hyaluronic acid" ], "sourceCount": 4, "sourceJurisdictions": [ "International overview", "Germany", "Australia" ], "sources": [ { "id": "ibsa-profhilo-family", "title": "Profhilo product line", "publisher": "IBSA Derma", "url": "https://ibsaderma.com/profhilo/profhilo/", "kind": "manufacturer", "jurisdiction": "International overview", "checkedAt": "2026-08-14", "supports": "Profhilo family identity and hyaluronic-acid material class." }, { "id": "ibsa-profhilo-de", "title": "Profhilo — Face & Neck", "publisher": "IBSA Germany", "url": "https://www.ibsagermany.de/produkte/profhilo.html", "kind": "manufacturer", "jurisdiction": "Germany", "checkedAt": "2026-08-14", "supports": "German manufacturer product listing and local product-information context." }, { "id": "tga-artg-profhilo-387132", "title": "PROFHILO 3.2% — ARTG 387132", "publisher": "Australian Therapeutic Goods Administration", "url": "https://www.tga.gov.au/resources/artg/387132", "kind": "regulator", "jurisdiction": "Australia", "checkedAt": "2026-08-15", "supports": "The active Australian Class III medical-device record for the named PROFHILO 3.2%, 32 mg H-HA plus 32 mg L-HA per 2 ml presentation and its manufacturer." }, { "id": "ibsa-profhilo-australia-ifu", "title": "Profhilo — Australian Instructions for Use", "publisher": "IBSA Farmaceutici Italia / IBSA Derma Australia", "url": "https://www.ibsaderma.com.au/wp-content/uploads/2023/11/Profhilo-IFU-AUS-new.pdf", "kind": "instructions-for-use", "jurisdiction": "Australia", "checkedAt": "2026-08-15", "supports": "The product-specific Profhilo identity, 2 ml presentation, sodium-hyaluronate composition, professional-use context, precautions, and adverse-event wording for the attached Australian IFU." } ], "evidenceDossier": { "preparedAt": "2026-08-15", "readiness": "ready-for-clinical-review", "readinessNote": "A product-specific Australian regulator record and official Profhilo IFU now support the family identity, named 2 ml presentation, and bounded material wording.", "jurisdictions": [ { "code": "AU", "name": "Australia", "productNames": [ "PROFHILO 3.2% — 32 mg (H-HA) + 32 mg (L-HA) / 2 ml" ], "evidenceLevel": "regulator-record", "sourceIds": [ "tga-artg-profhilo-387132", "ibsa-profhilo-australia-ifu" ], "finding": "The TGA records the named 2 ml PROFHILO presentation as an active Class III medical device manufactured by IBSA Farmaceutici Italia, with a product-specific Australian IFU available from IBSA.", "limitation": "This Australian record and IFU do not establish the status, presentation, intended purpose, or availability of Profhilo, Profhilo Body, or Profhilo Structura in another jurisdiction." }, { "code": "DE", "name": "Germany", "productNames": [ "Profhilo" ], "evidenceLevel": "manufacturer-documentation", "sourceIds": [ "ibsa-profhilo-de" ], "finding": "IBSA Germany documents Profhilo in its German product portfolio and provides local product context.", "limitation": "This German manufacturer page is not used to infer conformity status or to import the Australian presentation or IFU into Germany." }, { "code": "INTL", "name": "International / source market not limited to one jurisdiction", "productNames": [ "Profhilo", "Profhilo Structura", "Profhilo Body" ], "evidenceLevel": "manufacturer-documentation", "sourceIds": [ "ibsa-profhilo-family" ], "finding": "IBSA Derma documents the Profhilo family and its hyaluronic-acid identity.", "limitation": "The international page supports family identity only and does not make the separately named variants interchangeable." } ], "claims": [ { "id": "profhilo-family-identity", "kind": "identity", "statement": "Profhilo is documented by IBSA as a family that includes separately named product variants.", "scope": "Family discovery only; Profhilo, Profhilo Body, and Profhilo Structura remain separately named products, and approval of this family page does not approve their catalogue-variant routes.", "sourceIds": [ "ibsa-profhilo-family", "ibsa-profhilo-de", "tga-artg-profhilo-387132" ] }, { "id": "profhilo-material-family", "kind": "material", "statement": "The attached Australian record and IFU identify a PROFHILO 2 ml presentation containing 32 mg high-molecular-weight plus 32 mg low-molecular-weight hyaluronic-acid sodium salt.", "scope": "Exact composition is limited to the named Australian 2 ml presentation; it is not inferred for Profhilo Body, Profhilo Structura, or any other presentation.", "sourceIds": [ "tga-artg-profhilo-387132", "ibsa-profhilo-australia-ifu" ] }, { "id": "profhilo-australia-regulatory-context", "kind": "regulatory-context", "statement": "Australia's TGA records the named PROFHILO 3.2% 2 ml presentation as an active Class III medical device under ARTG 387132.", "scope": "Australia and this exact ARTG record only; no approval, availability, or classification is inferred for another market or family variant.", "sourceIds": [ "tga-artg-profhilo-387132" ] } ], "reviewerFocus": [ "Confirm that the Australian 2 ml presentation remains visibly separated from other Profhilo family variants and jurisdictions." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-15", "datasetVersion": "2026.08.15.1", "notes": "Approved for publication after the product-specific Australian TGA record and official Profhilo IFU closed the primary-source gap; the recorded jurisdiction and variant limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/profhilo/" }, { "slug": "kybella", "name": "Kybella / Belkyra", "manufacturer": "AbbVie (Allergan Aesthetics)", "classification": "Deoxycholic-acid prescription injectable", "aliases": [ { "name": "Kybella", "scope": "United States brand name in the attached source" }, { "name": "Belkyra", "scope": "Canadian brand name in the attached source" } ], "materialNames": [ "deoxycholic acid" ], "sourceCount": 3, "sourceJurisdictions": [ "United States", "Canada" ], "sources": [ { "id": "allergan-kybella-us", "title": "Kybella official site", "publisher": "Allergan Aesthetics, an AbbVie company", "url": "https://www.mykybella.com/", "kind": "manufacturer", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "United States product and safety-information context." }, { "id": "dailymed-kybella-us", "title": "KYBELLA — current United States drug label", "publisher": "U.S. National Library of Medicine (DailyMed)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553", "kind": "approved-label", "jurisdiction": "United States", "checkedAt": "2026-08-14", "supports": "The current US Kybella prescription-drug identity, label context, dosage form, and deoxycholic-acid naming." }, { "id": "health-canada-belkyra", "title": "BELKYRA — Drug Product Database record", "publisher": "Health Canada", "url": "https://health-products.canada.ca/dpd-bdpp/info?code=92869&lang=eng", "kind": "regulator", "jurisdiction": "Canada", "checkedAt": "2026-08-14", "supports": "The Canadian Belkyra product identity, marketed status in that database, prescription schedule, dosage form, company, and deoxycholic-acid ingredient record." } ], "evidenceDossier": { "preparedAt": "2026-08-14", "readiness": "ready-for-clinical-review", "readinessNote": "Current official product records are attached for Kybella in the US and Belkyra in Canada.", "jurisdictions": [ { "code": "US", "name": "United States", "productNames": [ "KYBELLA" ], "evidenceLevel": "approved-product-information", "sourceIds": [ "dailymed-kybella-us" ], "finding": "Current US labeling records KYBELLA as a prescription deoxycholic-acid injection.", "limitation": "The US label is specific to Kybella and does not establish another market's brand, label, or availability." }, { "code": "CA", "name": "Canada", "productNames": [ "BELKYRA" ], "evidenceLevel": "regulator-record", "sourceIds": [ "health-canada-belkyra" ], "finding": "Health Canada's Drug Product Database records BELKYRA as a marketed prescription solution containing deoxycholic acid.", "limitation": "The Canadian record does not make Belkyra interchangeable with Kybella or establish status outside Canada." } ], "claims": [ { "id": "kybella-belkyra-names", "kind": "alias", "statement": "Kybella and Belkyra are separately documented US and Canadian deoxycholic-acid product identities in this discovery profile.", "scope": "The grouping is for identity discovery only and does not assert presentation or label equivalence.", "sourceIds": [ "dailymed-kybella-us", "health-canada-belkyra" ] }, { "id": "kybella-material", "kind": "material", "statement": "Both attached official product records name deoxycholic acid.", "scope": "Shared ingredient naming does not establish interchangeability, dosing, or authorised use across jurisdictions.", "sourceIds": [ "dailymed-kybella-us", "health-canada-belkyra" ] } ], "reviewerFocus": [ "Confirm that the legacy Kybella URL clearly distinguishes the Canadian Belkyra record from the US label." ] }, "clinicalReviewStatus": "approved-for-publication", "clinicalReviewAssignment": { "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "assignedAt": "2026-08-14", "scope": "All Product Atlas family-profile evidence dossiers", "status": "review-complete-for-ready-dossiers" }, "clinicalReview": { "decision": "approved-for-publication", "reviewerName": "Dr. Adi Zoabi", "reviewerQualifications": "Dermatologist", "reviewedAt": "2026-08-14", "datasetVersion": "2026.08.15.1", "notes": "Prior approval carried forward into dataset 2026.08.15.1 because this profile's claims and sources are unchanged; the recorded jurisdiction and claim limitations remain mandatory." }, "publicationStatus": "published", "reviewReady": true, "indexable": true, "url": "https://aestheticpass.com/products/kybella/" } ] }