SCANDONEST 3% mepivacaine 66 mg/2.2 mL injection cartridge, Specialites Septodont Pty Ltd, CON-675
Product name
SCANDONEST 3% mepivacaine 66 mg/2.2 mL injection cartridge
Sponsor name
Specialites Septodont Pty Ltd
Consent start
Consent no.
CON-675
Standard
The Therapeutic Goods Order No. 91 '“ Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform with the requirements of TGO 91 due to global
supply chain issues in introducing the TGO 91 compliant labels into the
manufacturing process. However, the product is supplied with labels that have
been approved by the TGA, assessed against TGO 69 requirements.
Therapeutic product type
Prescription medicines