ARTG Entry
EMLA
ARTG entry for EMLA (lidocaine, prilocaine), ARTG 60820 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Aspen Pharmacare
- Active ingredient: lidocaine, prilocaine
- Therapeutic area: Pain Management
I apologize, but
I cannot write a Brand Dossier for EMLA based on the documents provided.
The documents you have supplied contain detailed product information for **Oraqix® Periodontal Gel** (a lidocaine and prilocaine combination for use in periodontal pockets) and only minimal ARTG registration records for EMLA (listing three variants: cream kit, cream tube, and dermal patch, with first listings between 1991 and 1997).
The ARTG records for EMLA lack the clinical, safety, dosing, contraindication, and regulatory history information necessary to populate the required dossier sections. The Oraqix product information, while comprehensive, describes a different medicine with different indications and formulation, and cannot be used to support claims about EMLA's properties.
To produce an accurate Brand Dossier for EMLA, I would need source documents that contain: — Product information (PI) or equivalent clinical data for EMLA specifically — PBAC assessment reports or decisions relevant to EMLA — Safety and efficacy data for EMLA formulations — Dosing guidance for EMLA — Regulatory history details (ARTG approval dates, any AusPAR, Black Triangle status)
I recommend obtaining the current EMLA Product Information document and any available PBAC or regulatory assessment records from the TGA.