ALUSTAL HOUSE DUST MITES EXTRACT INITIAL TREATMENT european house dust mite and american house dust mite injection suspension vial composite pack, Stallergenes Australia Pty Ltd, CON-900
Product name
ALUSTAL HOUSE DUST MITES EXTRACT INITIAL TREATMENT european house dust mite and american house dust mite injection suspension vial composite pack
Sponsor name
Stallergenes Australia Pty Ltd
Consent start
Consent no.
CON-900
Standard
Default standard for bacterial endotoxin (Ph. Eur. 2.6.14 and 5.1.10)
Non-compliance with standard
The products do not conform to the requirements of default standard for
bacterial endotoxin (Ph. Eur. 2.6.14 and 5.1.10) in that the products do not
comply with the monograph endotoxin limit of ‰¤ 100 IU/mL.
Conditions imposed
The products to which this consent applies are those specified in the request
submitted (ARTG 132680 and 132725).
Therapeutic product type
Prescription medicines