Stylage S Lidocaine - Synthetic-fluid tissue reconstructive material, anaesthetic

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
01-12-2017

Dostopno od:

AA-Med Pty Ltd

Razred:

Class III

Izdeluje:

Laboratoires VIVACY 252 Rue Douglas Engelbart Archamps Technopole, Archamps, 74160 France

Terapevtsko območje:

47887 - Synthetic-fluid tissue reconstructive material, anaesthetic

Terapevtske indikacije:

Sterile, cross-linked hyaluronic acid gel with physiological pH and osmolarity, which incorporates a medicinal substance (Lidocaine Hydrochloride). When injected, the device generates volume by filling in the treatment area and is reabsorbed over time. The device is packed in a 0.8mL pre-filled syringe. The ancillary role of Lidocaine Hydrochloride is to reduce pain associated with injections into the skin. Stylage? S lidoca?ne is an injectable hyaluronic acid gel, intended to fill in facial skin depression (i.e. treatment of nasolabial folds) by injection into the dermis, by a skilled legally qualified practitioner trained in techniques for injecting implants. The lidocaine hydrochloride is intended to reduce pain linked to the injection.

Status dovoljenje:

A

Datum dovoljenje:

2017-08-17

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