ARAVA Leflunomide 10 mg tablet bottle, Sanofi-Aventis Australia Pty Ltd, CON-972
Product name
ARAVA Leflunomide 10 mg tablet bottle
Sponsor name
Sanofi-Aventis Australia Pty Ltd
Batches
1PN6A
Consent start
Consent no.
CON-972
Standard
Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95) subsection 9(1), 9(2) and 9(3)
Non-compliance with standard
The sponsor does not hold and could not provide evidence of compliance with a
standard mentioned in Subsesction 9(1) of TGO 95.
Conditions imposed
Approval has been granted for replacement TGO 95-compliant packaging for all
future batches.
Therapeutic product type
Prescription medicines