IBSA Derma
A source-linked family profile for Profhilo and named variants in the operational catalogue.
Evidence status: Evidence dossier · named clinical review approved
Identity record
Manufacturer and category are catalogue fields. They are not, by themselves, a regulatory classification or verification of the exact marketed presentation.
Jurisdiction map
Product names and regulatory context do not travel automatically between countries. Each row below is limited to its named source market.
AU
Named record
PROFHILO 3.2% — 32 mg (H-HA) + 32 mg (L-HA) / 2 ml
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.
Limit: 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.
DE
Named record
Profhilo
IBSA Germany documents Profhilo in its German product portfolio and provides local product context.
Limit: This German manufacturer page is not used to infer conformity status or to import the Australian presentation or IFU into Germany.
INTL
Named record
Profhilo · Profhilo Structura · Profhilo Body
IBSA Derma documents the Profhilo family and its hyaluronic-acid identity.
Limit: The international page supports family identity only and does not make the separately named variants interchangeable.
Catalogue relationship
Provenance
IBSA Derma · International overview
Supports: Profhilo family identity and hyaluronic-acid material class.
IBSA Germany · Germany
Supports: German manufacturer product listing and local product-information context.
Australian Therapeutic Goods Administration · Australia
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.
IBSA Farmaceutici Italia / IBSA Derma Australia · Australia
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.
Claim ledger
Identity
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.
Material / active name
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.
Regulatory context
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.
Use boundary
Separate reference from record-keeping
Aesthetic Pass records treatment identity, lot information, photos, and injection maps. The atlas itself never chooses a product or treatment.
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