HYALASE hyaluronidase 1500IU powder for injection ampoule, Sanofi-Aventis Australia Pty Ltd , CON-785
Product name
HYALASE hyaluronidase 1500IU powder for injection ampoule
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Batches
PVR10170, PWR10001 and PWR10002
Consent start
Consent no.
CON-785
Standard
The European Pharmacopeia test for Loss on Drying (LOD) specification
Non-compliance with standard
The European Pharmacopeia test for Loss on Drying (LOD) specification, which is
LOD ‰¤ 5.0%.
Conditions imposed
This exemption only applies to drug substance batches PVR10170, PWR10001 and
PWR10002, as specified in the request.
Therapeutic product type
Prescription medicines