CSL FUNNEL WEB SPIDER ANTIVENOM (RABBIT) 125U powder for injection vial, Seqirus Pty Ltd, CON-187
Product name
CSL FUNNEL WEB SPIDER ANTIVENOM (RABBIT) 125U powder for injection vial
Sponsor name
Seqirus Pty Ltd
Batches
050410201
Consent start
Consent no.
CON-187
Standard
European Pharmacopoeia.
Non-compliance with standard
The product exceeds the test specification for water content.
Conditions imposed
1. This consent applies only to CSL FUNNEL WEB SPIDER ANTIVENOM batch
050410201;
2. Non-compliance with the European Pharmacopoeia requirements is limited to
the tests detailed in the application;
3. The shelf-life of the batch 050410201 will be reduced from 36 months to
24 months; and
4. A long term stability trial for batch 050410201 will be initiated to
monitor the ongoing quality of the drug product. The Therapeutic Goods
Administration should be notified in case of an adverse change in the quality of
the product and appropriate actions should be taken to determine if recall of
the product is necessary.
Therapeutic product type
Prescription medicines